[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"functional-dyspepsia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:functional-dyspepsia":29},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,41,0,25,[9,44,76,105,132,155,176,207,227,251,277,302,335,368,391,423,451,480,509,529,558,577,606,627,641],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100652428","identifying-multidimensional-signatures-of-gastric-interoception-in-functional-dyspepsia-100652428",false,"NCT07772167","Identifying Multidimensional Signatures of Gastric Interoception in Functional Dyspepsia","IMAGINE","Participant Inclusion Criteria--\n\nFunctional Dyspepsia Group:\n\n* Males and females; ages 18-65 years\n* Rome V functional dyspepsia post-prandial distress syndrome subtype\n* Negative upper endoscopy or upper GI series to rule out structural\u002Forganic cause for FD\n* greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)\n* Fluent in English\n* Willing and able to provide informed consent\n* Stable dose for 30 days prior to Visit 1 if on a neuropsychiatric medication (e.g., TCA, SNRI, SSRI mirtazapine, atypical antipsychotic, gabapentin, buspirone, pregabalin)\n* No current plans to initiate a new or change dosing on a neuropsychiatric medication within the study period\n\nAnorexia Nervosa Group:\n\n* Males and females; ages 18-65 years\n* DSM-5 anorexia restricting-type by the Eating Disorder Module in the Diagnostic Interview for Mood, Anxiety, and OCD and related Neuropsychiatric Disorders (DIAMOND)\n* greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)\n* Fluent in English\n* Willing and able to provide informed consent\n* Stable dose for 30 days prior to Visit 1 if on an SSRI\n* No current plans to initiate a new neuromodulator\n* No current plans to initiate a new SSRI or change dosing on an SSRI\n\nHealthy Controls:\n\n* Males and females; ages 18-65 years\n* BMI greater than or equal to 18.5 kg\u002Fm2\n* Fluent in English\n* Willing and able to provide informed consent\n\nParticipant Exclusion Criteria--\n\nFunctional Dyspepsia Group:\n\n* Presence of other conditions that could explain the patient's symptoms by medical chart:\n\n  * Pyloric or intestinal obstruction (by EGD, UGI, or Abdominal CT)\n  * Active H.pylori (by CLO test or stool antigen test)\n  * Active inflammatory bowel disease\n  * Eosinophilic gastroenteritis or eosinophilic esophagitis\n  * Acute renal failure\n  * Chronic renal failure (serum creatinine \\>3 mg\u002FdL) and\u002For on hemodialysis or peritoneal dialysis\n  * Acute liver failure\n  * Any acute gastrointestinal process\n  * Any plausible structural or metabolic causes\n  * Heartburn as predominant symptom\n  * History of peptic ulcer\n* Symptom resolution with antisecretory therapy (PPI use for other reasons that did not resolve FD symptoms will be allowed)\n* Endorses any contraindications to MRI\n* Body weight of 450 lbs or greater or BMI of 50 kg\u002Fm2 or greater (limit of MRI table)\n* Allergy to pineapple (used in the test meal during MRI)\n* History of GI tract surgery or any serious medical condition (e.g., cancer)\n* Pregnancy\u002Fbreastfeeding within the last 8 weeks\n* Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart\n* Narcotic analgesics greater than three days per week\n* Cannabinoid use greater than three days per week\n* Intellectual disability by history\n* Illiteracy\n* History of weight\u002Fshape-based eating disorder including anorexia nervosa by DIAMOND\n* Current binge eating by DIAMOND\n* Current self-induced vomiting by DIAMOND\n* Current laxative or diuretic misuse by DIAMOND\n* Current substance\u002Falcohol use disorder within past year by DIAMOND\n* Current\u002Fhistory of psychosis by DIAMOND\n* Current mania by DIAMOND\n* Active suicidal ideation by modified DIAMOND abbreviated suicide module; passive suicidal ideation is allowed\n* Inability or unwillingness to consume food by mouth\n* Inability to provide informed consent\n\nAnorexia Nervosa Group:\n\n* Diagnosis of chronic gastrointestinal disorder\n* Rome V functional dyspepsia\n* Endorses any contraindications to MRI\n* Body weight of 450 lbs or greater or BMI of 50 kg\u002Fm2 or greater (limit of MRI table)\n* Allergy to pineapple (used in the test meal during MRI)\n* History of GI tract surgery or any serious medical condition (e.g., cancer)\n* Pregnancy\u002Fbreastfeeding within the last 8 weeks\n* Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart\n* Narcotic analgesics greater than three days per week\n* Cannabinoid use greater than three days per week\n* Intellectual disability by history\n* Illiteracy\n* Current binge eating by DIAMOND\n* Current self-induced vomiting by DIAMOND\n* Current laxative or diuretic misuse by DIAMOND\n* Current substance\u002Falcohol use disorder within past year by DIAMOND\n* Current\u002Fhistory of psychosis by DIAMOND\n* Current mania by DIAMOND\n* Active suicidal ideation by DIAMOND abbreviated suicide module; passive suicidal ideation is allowed\n* Inability or unwillingness to consume food by mouth\n* Inability to provide informed consent\n* Current use of neuropsychiatric medication other than an SSRI (e.g., TCA, SNRI, mirtazapine, atypical antipsychotic, gabapentin, buspirone, pregabalin)\n\nHealthy Controls:\n\n* Diagnosis of chronic gastrointestinal or pain disorder\n* Rome V functional dyspepsia\n* greater than or equal to 5.5 gut interoceptive awareness score (by VSI awareness subscale)\n* Current use of a medication known to influence gastric sensorimotor functions (including neuromodulators and SSRIs)\n* Active psychiatric disorder including a feeding\u002Feating disorder by DIAMOND\n* Endorses any contraindications to MRI\n* Body weight of 450 lbs or greater or BMI of 50 kg\u002Fm2 or greater (limit of MRI table)\n* Allergy to pineapple (used in the test meal during MRI)\n* History of GI tract surgery or any serious medical condition (e.g., cancer)\n* Pregnancy\u002Fbreastfeeding within the last 8 weeks\n* Uncontrolled diabetes (indicated by HbA1c greater than or equal to 7%) by chart\n* Narcotic analgesics greater than three days per week\n* Cannabinoid use greater than three days per week\n* Intellectual disability by history\n* Illiteracy\n* Current binge eating by DIAMOND\n* Current self-induced vomiting by DIAMOND\n* Current laxative or diuretic misuse by DIAMOND\n* Current substance\u002Falcohol use disorder within past year by DIAMOND\n* Current\u002Fhistory of psychosis by DIAMOND\n* Current mania by DIAMOND\n* Active suicidal ideation by DIAMOND modified suicide module; passive suicidal ideation is allowed\n* Inability or unwillingness to consume food by mouth\n* Inability to provide informed consent",true,"ALL","18 Years","65 Years",{"count":22,"type":23},150,"ESTIMATED","INTERVENTIONAL",[26],"NA","This study is being conducted to investigate gut-brain communication in individuals with functional dyspepsia and anorexia nervosa. The hope is that what the investigators learn from this study will improve the understanding the conditions better to improve treatments.",[29,30],"Functional Dyspepsia","Anorexia Nervosa","RECRUITING","2026-08-14",{"date":34,"type":35},"2026-08-19","ACTUAL",{"date":37,"type":35},"2026-03-16",{"date":39,"type":23},"2031-03",{"name":41,"class":42},"Massachusetts General Hospital","OTHER",1,{"id":45,"slug":46,"hasResults":12,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":4,"eligibilityCriteria":50,"healthyVolunteers":12,"sex":18,"minAge":51,"maxAge":52,"enrollmentInfo":53,"targetDuration":4,"studyType":24,"phases":55,"briefSummary":56,"conditions":57,"keywords":64,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":67,"startDateStruct":69,"completionDateStruct":71,"leadSponsor":73,"locationsCount":75},"100610081","feasibility-study-of-a-guided-imagery-therapy-mobile-application-for-functional-abdominal-pain-disorders-in-children-100610081","NCT07222943","Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children","Open-Labelled Feasibility Study of a Guided Imagery Therapy Mobile Application for Functional Abdominal Pain Disorders in Children","Inclusion Criteria:\n\n* Texas Children's Pediatrics patients 7 to 12 years old at enrollment\n* A Rome IV Functional Abdominal Pain Disorder as defined by a 2-week abdominal pain and stooling diary\n* Both children and their primary caregivers must be able to read and communicate in English proficiently to understand the intervention's audio therapy sessions and psychometric instruments.\n\nExclusion Criteria:\n\n* Previous abdominal surgeries\n* Co-morbid conditions associated with abdominal pain (e.g., cystic fibrosis)\n* Autism\n* Significant development delay\n* Psychosis\n* Prior experience with cognitive behavioral therapy or guided imagery therapy to treat chronic abdominal pain\n* Alarm symptoms that warrant further medical evaluation (e.g., blood in stool)","7 Years","12 Years",{"count":54,"type":23},63,[26],"Chronic abdominal pain is common among children, and the majority of cases are attributed to functional abdominal pain disorders. One approach to treating these disorders is by using psychological therapies. This clinical trial aims to see how well pre-recorded guided imagery therapy sessions help children's abdominal pain when delivered via a mobile application (app) on a smartphone or tablet.\n\nParticipants will complete a baseline abdominal pain and stooling diary to determine eligibility, as well as other surveys. Eligible participants will be given access to the guided imagery therapy mobile application.\n\nThis intervention asks participants to listen to a 10- to 15-minute GIT session 5 out of 7 days per week for 8 weeks, in addition to their usual care for their abdominal pain. Then, participants will complete another abdominal pain and stooling diary, along with other psychometric surveys, at the end of this intervention period. Participants will also collect another diary and surveys 3 months post-treatment.",[58,59,60,61,62,63,29],"Functional Abdominal Pain Disorders","Irritable Bowel Syndrome (IBS)","Functional Gastrointestinal Disorders (FGIDs)","Gastrointestinal and Digestive Disorder","Abdominal Pain\u002F Discomfort","Pain",[65,66],"abdominal pain","irritable bowel syndrome",{"date":68,"type":35},"2026-08-17",{"date":70,"type":23},"2026-09-01",{"date":72,"type":23},"2027-04-30",{"name":74,"class":42},"Baylor College of Medicine",2,{"id":77,"slug":78,"hasResults":12,"nctId":79,"briefTitle":80,"officialTitle":80,"acronym":81,"eligibilityCriteria":82,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":83,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":85,"conditions":86,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":95,"lastUpdatePostDateStruct":96,"startDateStruct":98,"completionDateStruct":100,"leadSponsor":102,"locationsCount":104},"100652145","the-prevalence-and-the-pathophysiological-role-of-non-helicobacter-pylori-helicobacter-spp-in-well-defined-gastric-diseases-and-pre--malignancies-100652145","NCT07770126","The Prevalence and the Pathophysiological Role of Non-Helicobacter Pylori Helicobacter Spp. in Well-defined Gastric Diseases and (Pre-) Malignancies","HELIS","Inclusion Criteria:\n\n* part of the study population\n\nExclusion Criteria:\n\n* Patients with a history of H. pylori infection diagnosed by serology, on gastric biopsy, by breath test or on antigen test in stool samples.\n* Pregnancy.\n* Underage patients (\\\u003C 18 years).",{"count":22,"type":23},"OBSERVATIONAL","The goal of this clinical trial is to discover the prevalence of NHPH bacteria (Non-Helicobacter pylori Helicobacter species) in patients with one of the following conditions:\n\n1. Functional dyspepsia following the Rome IV criteria\n2. Active chronic gastritis, non-H. pylori induced atrophic gastritis, intestinal metaplasia and non-H.pylori gastric dysplasia\n3. Gastric cancer, including siewert type 2 and 3 esophagastric junction cancers In addition, patients undergoing bariatric surgery are included as a control group. This study will be conducted using a prospective analysis in the three targeted study populations. Biopsy specimens routinely taken during the medical procedure or via the resected material in patients belonging to the target groups will be used.\n\nExclusion criteria:\n\n* Patients with a history of H. pylori infection diagnosed by serology, on gastric biopsy, by breath test or on antigen test in stool samples.\n* Pregnancy.\n* Underage patients (\\\u003C 18 years).",[29,87,88,89,90,91,92,93,94],"Gastritis","Gastritis Chronic","Gastric Cancer (GC)","Atrophic Gastritis","Intestinal Metaplasia of Gastric Mucosa","Dysplasia Stomach","Helicobacter Infection","NHPH Prevalence","2026-08-12",{"date":97,"type":35},"2026-08-18",{"date":99,"type":35},"2025-02-24",{"date":101,"type":23},"2028-03",{"name":103,"class":42},"Universiteit Antwerpen",3,{"id":106,"slug":107,"hasResults":12,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":4,"eligibilityCriteria":111,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":112,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":114,"conditions":115,"keywords":120,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":124,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":75},"100650607","liver-steatosis-and-fibrosis-in-non-celiac-wheat-sensitivity-patients-a-prospective-study-100650607","NCT07750535","Liver Steatosis and Fibrosis in Non-Celiac Wheat Sensitivity Patients: a Prospective Study","Prevalence and Risk Factors of Liver Steatosis and Fibrosis in Non-Celiac Wheat Sensitivity Patients: a Prospective Study","The inclusion\u002Fexclusion criteria used to select the study population have been previously validated in other retrospective studies. Additional exclusion criteria related to steatosis and other liver diseases and specifically required for this study were adopted.\n\nInclusion criteria for Non-Celiac Wheat Sensitivity (NCWS) patients\n\n* age \\>18 and \\\u003C65 years;\n* subjects with wheat-dependent symptoms, both gastrointestinal and extra-intestinal;\n* negativity of IgA and IgG anti-deamidated gliadin peptide (DPG) antibodies, immunoglobulin (Ig)A and IgG anti-tissue transglutaminase (tTG) antibodies, and anti-endomysial antibodies (EMA);\n* absence of duodenal villous atrophy, documented in all patients carrying the human leukocyte antigen (HLA) DQ2 and\u002For DQ8 haplotypes (therefore regardless of the negativity of celiac disease (CeD)-specific serum antibodies), evaluated when the patients had consumed a minimum of 100g of pasta and\u002For bread a day, for at least 45 days;\n* absence of IgE-mediated wheat allergy (WA): negative skin prick-test and\u002For specific serum IgE assay for wheat, gluten and gliadin);\n* resolution of symptoms on a strict standard elimination diet (i.e. extended oligoantigenic, excluding wheat, cow's milk, egg, tomato and chocolate and other foods self-reported by the patient as causing symptoms), followed for at least 4 weeks, and the recurrence of the same symptoms after double-blind placebo-controlled challenge (DBPCC) with wheat (for further details see below);\n* complete medical records;\n* duration of follow-up longer than 12 months after initial diagnosis, with at least 2 outpatient visits during the follow-up period.\n\nInclusion criteria for Irritable Bowel Syndrome\u002FFunctional Dyspepsia (IBS\u002FFD) and other functional gastrointestinal disorders unrelated to NCWS or other food allergies\u002Fintolerances patients\n\n* age \\>18 and \\\u003C65 years;\n* subjects diagnosed with IBS\u002FFD and other functional gastrointestinal disorders, according to the Rome IV classification, 1 who did not specifically report symptoms\u002Fsigns, whether gastrointestinal or extra-intestinal, following ingestion of wheat or other foods and who did not respond to gluten-free diet (GFD).\n\nInclusion criteria for Celiac Disease (CeD) patients\n\n* age \\>18 and \\\u003C65 years;\n* subjects with gastrointestinal and extra-intestinal wheat-dependent symptoms that meet the diagnostic criteria of CeD 2: positivity of anti-tTG IgA and\u002For IgG antibodies and evidence of villous atrophy, according to the Marsh-Oberhuber classification, demonstrated by histology on duodenal biopsy;\n* clinical response to the GFD: resolution of gastrointestinal and\u002For extra-intestinal symptoms.\n\nExclusion criteria for all the patients enrolled in the study\n\n* self-exclusion of wheat from the diet and refusal to reintroduce it for diagnostic purposes, before entering the study;\n* drug abuse;\n* treatment with steroids and\u002For non-steroidal anti-inflammatory drugs in the 2 weeks before duodenal biopsy;\n* pregnancy or breastfeeding;\n* diagnosis of chronic inflammatory bowel disease or other organic pathologies affecting the digestive system (e.g., wheat allergy, microscopic colitis, diverticulitis, segmental colitis associated with diverticulosis, etc.), neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, and impairments limiting physical activity;\n* incomplete medical records;\n* lack of clinical follow-up for at least 12 months after diagnosis with \\>2 outpatient visits during the follow-up period.\n\nAdditional exclusion criteria related to liver steatosis and other liver diseases\n\n* absence of abdominal ultrasound (US) imaging performed before diagnosis (i.e. before starting the wheat-free\u002Fgluten-free diet in NCWS and CeD patients, and before any lifestyle modifications and\u002For drug\u002Fprebiotic\u002Fprobiotic intake in IBS\u002FFD patients);\n* incomplete clinical records, lacking the data considered for the present study;\n* chronic alcohol intake (\\>30 g\u002Fday for men and \\>20 g\u002Fday for women);\n* chronic hepatotropic virus infections \\[hepatitis B virus (HBV) and hepatitis C virus (HCV)\\];\n* autoimmune liver diseases;\n* congenital metabolic liver diseases (e.g. alpha-1 antitrypsin deficiency, hemochromatosis, Wilson's disease, porphyria, other storage diseases, etc.);\n* chronic long-term treatment with drugs associated with both macrovesicular (glucocorticoids, estrogens, tamoxifen, amiodarone, methotrexate, and 5-fluorouracil) and microvesicular (glucocorticoids, valproic acid, tetracycline, and zidovudine) steatosis.",{"count":113,"type":23},250,"Hypothesizing an intestinal barrier impairment as a common pathophysiological substrate of both Non Celiac Wheat Sensitivity (NCWS) and Metabolic Dysfunction-Associated Steatotic Liver Disease (MAFLD), in a retrospective cohort study (data not yet published), demographic, clinical, laboratory and histology data of NCWS patients at the time of diagnosis, were analyzed and compared to control subjects with Irritable Bowel Syndrome\u002FFunctional Dyspepsia (IBS\u002FFD) and freshly diagnosed Celiac Disease (CeD). NCWS diagnosis was performed by a double-blind placebo-controlled wheat challenge. Steatosis was confirmed by ultrasound examination. Our retrospective data showed that the frequency of liver of steatosis was lower in NCWS than in IBS patients. In addition, it seems that pre-diagnosis avoidance of wheat in NCWS correlates with protection from steatosis. A subset of NCWS patients, recently exposed to wheat, with clinical features suggesting increased IP, seems to be predisposed to liver steatosis and fibrosis.\n\nTo validate the results of the retrospective study, the researchers planned the present prospective study, to analyze the prevalence of liver steatosis and fibrosis, evaluated by ultrasound (US) examination, FibroScan analysis \\[CAP (Controlled Attenuation Parameter) and LSM (Liver Stiffness Measurement) values\\], FIB-4 (Fibrosis-4) index, and NFS \\[Non-alcoholic fatty liver disease (NAFLD) Fibrosis Score\\], in patients with NCWS at the time of diagnosis, comparing them with two control populations of newly diagnosed IBS\u002FFD and CeD patients.",[116,117,118,29,119],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Non Celiac Wheat Sensitivity","Irritable Bowel Syndrome","Celiac Disease",[121,122],"non-celiac wheat sensitivity","metabolic dysfunction-associated steatotic liver disease","2026-08-06",{"date":125,"type":35},"2026-08-11",{"date":127,"type":35},"2024-01-01",{"date":129,"type":23},"2030-12-31",{"name":131,"class":42},"University of Palermo",{"id":133,"slug":134,"hasResults":12,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":4,"eligibilityCriteria":138,"healthyVolunteers":12,"sex":18,"minAge":139,"maxAge":140,"enrollmentInfo":141,"targetDuration":4,"studyType":24,"phases":143,"briefSummary":145,"conditions":146,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":123,"lastUpdatePostDateStruct":147,"startDateStruct":149,"completionDateStruct":150,"leadSponsor":152,"locationsCount":43},"100646791","a-study-to-evaluate-the-efficacy-and-safety-of-da-9701-in-patients-with-functional-dyspepsia-100646791","NCT07686679","A Study to Evaluate the Efficacy and Safety of DA-9701 in Patients With Functional Dyspepsia","A Multicenter, Double-blind, Active-controlled, Randomized, Parallel, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of DA-9701 in Patients With Functional Dyspepsia","Main Inclusion Criteria:\n\n* Men or women aged 19 to 75 years, inclusive\n* Subjects diagnosed with functional dyspepsia according to the Rome IV criteria\n* Subjects with at least three symptoms rated as moderate or severe on the Gastrointestinal Symptom Score(GIS)\n* Subjects who voluntarily signed a consent form\n\nMain Exclusion Criteria:\n\n* Subjects with a history of organic diseases that could cause dyspepsia\n* Subjects with hypersensitivity to investigational drugs and similar drugs\n* Pregnant or breastfeeding women","19 Years","75 Years",{"count":142,"type":23},300,[144],"PHASE4","This study will evaluate the efficacy and safety of DA-9701 in patients with functional dyspepsia",[29],{"date":148,"type":35},"2026-08-10",{"date":123,"type":35},{"date":151,"type":23},"2027-10",{"name":153,"class":154},"Dong-A ST Co., Ltd.","INDUSTRY",{"id":156,"slug":157,"hasResults":12,"nctId":158,"briefTitle":159,"officialTitle":159,"acronym":160,"eligibilityCriteria":161,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":162,"targetDuration":4,"studyType":24,"phases":164,"briefSummary":165,"conditions":166,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":167,"lastUpdatePostDateStruct":168,"startDateStruct":170,"completionDateStruct":172,"leadSponsor":174,"locationsCount":43},"100543825","synergistic-gut-brain-axis-modulation-via-vagal-stimulation-and-support-therapy-in-functional-dyspepsia-100543825","NCT06360900","Synergistic Gut-brain Axis Modulation Via Vagal Stimulation and Support Therapy in Functional Dyspepsia","CONVERGE","Inclusion Criteria:\n\nAge 18-65 years old (inclusive)\n\n* Ability to give written consent and participate in behavioral intervention in English\n* Willingness to attend weekly treatment sessions over live video, daily self-administered transcutaneous auricular vagus nerve stimulation (taVNS) sessions, and engage in homework during treatment\n* Avoidance of alcohol, nicotine, and caffeine for 24 hours prior to study session\n* Diagnosis according to the Rome IV criteria for both epigastric pain syndrome and postprandial distress syndrome subtypes\n* Stable medical treatment for functional dyspepsia (FD) during 1 month before the study and during the study period\n\nExclusion Criteria:\n\n* Previous receipt of cognitive behavioral therapy (CBT) for gastrointestinal symptoms\n* Enteral or parenteral feeding\n* Previous gastrointestinal surgery, electrolyte disturbances, kidney dysfunction, renal insufficiency, or iron overload disorders\n* Estimated Glomerular Filtration Rate (eGFR) \\\u003C 60\n* Medications that affect gastrointestinal motility in addition to medications or products containing tetrahydrocannabinol (THC) will be stopped at least 7 days prior to the start of the study and for the duration of the study. However, anti-depressants (SSRI's, TCA's) may be allowed in order to reduce the risk of worsening neuropsychiatric disease, though it will be up to the study team and the Principal Investigator whether subjects on anti-depressants will be able to participate in the study\n* Intellectual disability by history\n* Diabetes, mitochondrial disease, severe autonomic dysfunction, and small fiber polyneuropathy\n* No active clinical acupuncture therapy\n* Illicit drugs or opioid usage\n* History of arrhythmias\n* Current pregnancy\u002Fbreastfeeding\n* Contraindications for magnetic resonance imaging (MRI) (implanted ferromagnetic objects, claustrophobia)\n* Weight \\> 450 lbs. (limit of the MRI table)\n* Allergy to pineapple (used in the test meal during MRI)\n* Any other condition interfering with study requirements, according to the Investigator",{"count":163,"type":23},80,[26],"The study aims at evaluating physiological and patient-reported outcomes for a dual intervention approach including a stimulation device and support therapy in patients with functional dyspepsia.",[29],"2026-07-14",{"date":169,"type":35},"2026-07-15",{"date":171,"type":35},"2025-10-29",{"date":173,"type":23},"2029-03",{"name":175,"class":42},"Spaulding Rehabilitation Hospital",{"id":177,"slug":178,"hasResults":12,"nctId":179,"briefTitle":180,"officialTitle":180,"acronym":4,"eligibilityCriteria":181,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":182,"targetDuration":4,"studyType":24,"phases":184,"briefSummary":185,"conditions":186,"keywords":188,"overallStatus":197,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":201,"completionDateStruct":203,"leadSponsor":205,"locationsCount":43},"100647762","efficacy-and-mechanistic-evaluation-of-hewei-anchang-formula-for-overlapping-gastrointestinal-symptoms-in-patients-with-coexisting-functional-dyspepsia-and-diarrhea-predominant-irritable-bowel-syndrome-100647762","NCT07715760","Efficacy and Mechanistic Evaluation of Hewei Anchang Formula for Overlapping Gastrointestinal Symptoms in Patients With Coexisting Functional Dyspepsia and Diarrhea-Predominant Irritable Bowel Syndrome","Inclusion Criteria:\n\n1. Meet the Rome IV diagnostic criteria for both functional dyspepsia (FD) and diarrhea-predominant irritable bowel syndrome (IBS-D).\n2. Meet the diagnostic criteria for liver-stomach disharmony syndrome in FD and liver qi stagnation with spleen deficiency syndrome in IBS-D.\n3. Aged 18-65 years, with no restriction on sex.\n4. Fully informed about the study and voluntarily provide written informed consent. -\n\nExclusion Criteria:\n\n1. Severe primary diseases of the cardiovascular, hepatic, renal, hematologic, or respiratory systems, or malignant tumors.\n2. Other organic gastrointestinal diseases, such as peptic ulcer or ulcerative colitis, or systemic diseases that may affect gastrointestinal motility, such as hyperthyroidism or diabetes mellitus.\n3. Current or anticipated continuous use of medications that may affect gastrointestinal function, including prokinetic agents, antidiarrheal agents, antidepressants, anxiolytics, gut microbiota-modulating agents, and antibiotics.\n4. A history of allergy to any study-related medication or a history of severe food allergy.\n5. Psychiatric disorders, intellectual impairment, or language impairment.\n6. Women who are planning pregnancy, pregnant, or breastfeeding.\n7. Current participation in another drug clinical trial or participation in another drug clinical trial within the previous 4 weeks.\n8. Severe anxiety or depression, as assessed using the Hospital Anxiety and Depression Scale (HADS). An anxiety subscale score of ≥15 is defined as severe anxiety, and a depression subscale score of ≥15 is defined as severe depression. Participants meeting the criterion for severe anxiety or severe depression on either subscale will be excluded.\n9. A suspected or confirmed history of alcohol or drug abuse, or other circumstances that, in the investigator's judgment, may reduce the likelihood of enrollment or complicate study participation, such as frequent changes in the work environment that may increase the risk of loss to follow-up. -",{"count":183,"type":23},120,[26],"1. To conduct a multicenter, randomized controlled trial across four hospitals to evaluate the efficacy of Hewei Anchang Formula in patients with overlapping gastrointestinal symptoms of functional dyspepsia (FD) and diarrhea-predominant irritable bowel syndrome (IBS-D), characterized by liver-stomach disharmony syndrome and liver stagnation-spleen deficiency syndrome, respectively. By leveraging the holistic regulatory effects of Chinese herbal formulas and the traditional Chinese medicine principle of \"treating different diseases with the same therapeutic approach,\" this study aims to generate high-level evidence for the management of overlapping gastrointestinal symptoms in functional gastrointestinal disorders (FGIDs) and to establish a standardized and scalable therapeutic strategy.\n2. To elucidate the potential mechanisms underlying the therapeutic effects of Hewei Anchang Formula on overlapping gastrointestinal symptoms of FD and IBS-D through multiple targets and pathways, with particular emphasis on modulation of the gut microbiota and the neuroendocrine-immune network.",[29,187],"Irritable Bowel Syndrome With Diarrhea",[189,190,191,192,193,194,195,196],"Hewei Anchang Formula","Overlapping Gastrointestinal Symptoms","Functional Gastrointestinal Disorders","Traditional Chinese Medicine","Chinese Herbal Medicine","Gut Microbiota","Metagenomics","Metabolomics","NOT_YET_RECRUITING","2026-07-11",{"date":200,"type":35},"2026-07-20",{"date":202,"type":23},"2027-01-01",{"date":204,"type":23},"2028-12-30",{"name":206,"class":42},"Xiyuan Hospital of China Academy of Chinese Medical Sciences",{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":4,"eligibilityCriteria":213,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":218,"lastUpdatePostDateStruct":219,"startDateStruct":221,"completionDateStruct":223,"leadSponsor":225,"locationsCount":43},"100646231","prevalence-of-functional-dyspepsia-in-a-rural-community-of-bangladesh--a-cross-sectional-study-100646231","NCT07694778","Prevalence of Functional Dyspepsia in a Rural Community of Bangladesh : A Cross Sectional Study","Prevalence of Functional Dyspepsia in Rural Community of Bangladesh: A Cross Sectional Study","Inclusion Criteria:\n\n* Age 18 years or above\n* Resident of the selected community\n\nExclusion Criteria:\n\n* Known diagnosis of organic GI diseases.(e.g., Peptic ulcer disease, Inflammatory Bowel Disease, celiac disease, Malignancy, Intestinal Tuberculosis)\n* Severe cognitive impairment, or critical illness\n* Individuals with a history of major abdominal surgery\n* Pregnant women",{"count":215,"type":23},730,"Functional dyspepsia (FD) is a common gastrointestinal disorder with an important impact on quality of life. There is a paucity of updated data on the prevalence of FD in rural areas of Bangladesh. The present study will be carried out to find the prevalence of FD in a community in rural Bangladesh. It also assesses potential risk factors. Eligible participants will first be evaluated for symptoms by a clinical interview using the standardized Rome IV functional dyspepsia questionnaire. Those who meet Rome IV criteria will then have an upper gastrointestinal endoscopy to exclude underlying organic diseases to establish a definitive diagnosis. Eventually patients with normal endoscopic findings will be diagnosed as having functional dyspepsia. This allows the accurate calculation of disease prevalence. Researchers will gather demographic information, lifestyle habits, and dietary patterns. The results will give important baseline data on rural FD burdens. Such data can inform community health care interventions.",[29],"2026-07-05",{"date":220,"type":35},"2026-07-10",{"date":222,"type":35},"2026-01-10",{"date":224,"type":23},"2026-12",{"name":226,"class":42},"Bangladesh Medical University",{"id":228,"slug":229,"hasResults":12,"nctId":230,"briefTitle":231,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":234,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":236,"conditions":237,"keywords":239,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":242,"lastUpdatePostDateStruct":243,"startDateStruct":245,"completionDateStruct":247,"leadSponsor":249,"locationsCount":104},"100581731","prokinetics-and-body-surface-gastric-mapping-in-dyspeptic-patients-baseline-and-treatment-effects-100581731","NCT06854120","Prokinetics and Body Surface Gastric Mapping in Dyspeptic Patients: Baseline and Treatment Effects","Body Surface Gastric Mapping in Patients With Dyspeptic Symptoms: Recordings at Baseline and on Medical Therapy","Inclusion Criteria:\n\n* Patients 18 years of age and older\n* Diagnosis of gastroparesis and\u002For functional dyspepsia\n* Being prescribed a prokinetic agent or symptom modulator for their clinical care\n* Able to undergo BSGM recording both before and during treatment\n* Able to give informed consent for undergoing a baseline BSGM recording and an additional recording while on treatment\n\nExclusion Criteria:\n\n* Under 18 years of age\n* Prior surgery on esophagus, stomach (appendectomy and cholecystectomy are allowed)\n* History of skin allergies or a history of extreme sensitivity to cosmetics or lotions\n* Pregnant women\n* No vulnerable groups such as prisoners, individuals with known cognitive impairment, or institutionalized individuals be involved",{"count":235,"type":23},125,"Functional dyspepsia and gastroparesis are common stomach disorders with symptoms like early satiety, nausea, and abdominal pain, and are often evaluated with gastric emptying tests, although the correlation with symptoms is weak. Prokinetic agents (e.g., metoclopramide, erythromycin) and symptom modulators (e.g., nortriptyline, mirtazapine) are commonly used, but selecting the right medication can be difficult, as it's often based on symptoms rather than the underlying gastric issues. Body Surface Gastric Mapping (BSGM) using the Gastric Alimetry device is a novel, non-invasive tool to assess gastric myoelectrical activity and symptoms. This study aims to perform two BSGM recordings-one before and one after medical therapy-to understand how medications affect gastric function and identify baseline BSGM factors that could predict responses to treatment, potentially guiding tailored therapies based on individual gastric dysfunction.",[238,29],"Gastroparesis",[238,29,240,241],"Gastric Motility","Body Surface Gastric Mapping","2026-06-08",{"date":244,"type":35},"2026-06-11",{"date":246,"type":35},"2025-02-26",{"date":248,"type":23},"2028-08-26",{"name":250,"class":42},"University of Auckland, New Zealand",{"id":252,"slug":253,"hasResults":12,"nctId":254,"briefTitle":255,"officialTitle":256,"acronym":257,"eligibilityCriteria":258,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":259,"targetDuration":4,"studyType":24,"phases":261,"briefSummary":262,"conditions":263,"keywords":264,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":43},"100592960","mechanism-of-fodmap-restriction-on-fgid-patients-100592960","NCT07000227","Mechanism of FODMAP Restriction on FGID Patients","Mechanism of FODMAP Restriction on Gut Microbiota and Gut Barrier Function in Functional Gastrointestinal Disorder Patients : A Randomised Controlled Trial","BRIDGE","Inclusion Criteria:\n\n* Aged 18 and above\n* Able to provide informed consent\n* Those with pre-existing irritable bowel syndrome (IBS) or functional dyspepsia (FD) or both screened by gastroenterologists\n* Meet the ROME III- Asian criteria for FGID\n* Able to communicate in Malay or English language\n\nExclusion Criteria:\n\n* Pregnant or lactating women\n* History declared by the participant of pre-existing gastrointestinal disorder, including but not limited to Inflammatory Bowel Disease, Coeliac Disease, Pancreatitis, Gallstone disease (biliary colic, cholecystitis), Diverticulitis\n* Cancer of any kind\n* Patients with reported history of previous resection of any part of the GI tract other than appendix or gall bladder, intestinal stoma\n* Habitual use of opiate analgesics likely to alter bowel function e.g. morphine\n* Use of antibiotics in the preceding two weeks and\u002For in the past one month\n* Consumption of probiotics, prebiotics or fibre supplements in the past one month\n* Enteral feeding or texture modified diet patients\n* Those with cognitive impairment or severe mental disorder (Alzheimer's, schizophrenia, bipolar disorder. etc)\n* Shift workers (e.g. Nurse, doctors)",{"count":260,"type":23},60,[26],"Brief Summary :\n\nThe goal of this clinical trial is to investigate the effects of differing FODMAP diets on gut microbiota, gut barrier function, symptom severity, quality of life, and psychological status in FGID patients. The main question it aims to answer is :\n\nHow does diets with differing FODMAP content affect the gut microbiota, gut barrier function, symptom severity, psychological status and quality of life in patients with FGID ? Researchers will compare low FODMAP diet, Gentle FODMAP diet and Traditional Dietary Advice (NICE guidelines) to see which diet is more suitable and effective for Malaysian FGID patients.\n\nParticipants will :\n\nBe given either low FODMAP diet, Gentle FODMAP diet or Traditional Dietary Advice intervention and will be required to follow the intervention for two weeks.\n\nBe required to provide stool and blood samples during baseline and intervention Record 4 day food diary and complete assessing questionnaires during baseline and intervention",[60,59,29],[265,118,29,266,267],"Functional Gastrointestinal Disorder","FODMAP Restriction","Gentle FODMAP","2026-05-08",{"date":270,"type":35},"2026-05-11",{"date":272,"type":35},"2025-07-20",{"date":274,"type":23},"2026-09-30",{"name":276,"class":42},"Universiti Kebangsaan Malaysia Medical Centre",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":24,"phases":285,"briefSummary":286,"conditions":287,"keywords":289,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":294,"lastUpdatePostDateStruct":295,"startDateStruct":297,"completionDateStruct":299,"leadSponsor":301,"locationsCount":75},"100639939","ncws-or-ibsfd-in-relatives-of-cd-patients-100639939","NCT07584473","NCWS or IBS\u002FFD in Relatives of CD Patients","Inclusion criteria\n\n* CD patient's relatives\n* \\>18 years old\n* reporting IBS\u002FFD-like and extraintestinal (EI) symptoms\n\nExclusion criteria\n\n* self-exclusion of wheat from the diet and refuse to reintroduce it for diagnostic purposes;\n* drug and\u002For alcohol (\\>30 g\u002Fday for men and \\>20 g\u002Fday for women) abuse;\n* treatment with steroids and\u002For non-steroidal anti-inflammatory drugs in the 2 weeks before duodenal biopsy;\n* pregnancy or breastfeeding;\n* diagnosis of chronic inflammatory bowel disease or other organic pathologies affecting the digestive system \\[e.g., IgE-mediated Wheat Allergy (WA), microscopic colitis, diverticulitis, segmental colitis associated with diverticulosis, etc.\\], neurological diseases, major psychiatric disorders, infectious diseases, immunological deficiencies, and impairments limiting physical activity.",{"count":284,"type":23},600,[26],"Over 50% of non-celiac wheat sensitivity (NCWS) patients are HLA DQ2\u002FDQ8 positive and often have a Celiac Disease (CD) family history. Studies have identified a subgroup of NCWS patients whose clinical and immunological features are closer to CD than to irritable bowel syndrome\u002Ffunctional dyspepsia (IBS\u002FFD) ('inflammatory subgroup'). The investigators hypothesized that among CD patient's relatives, there might be a high number of NCWS subjects, who hypothetically belong to the 'inflammatory subgroup'. Therefore, the aim of this multi-step project is to identify the prevalence of both self-reported NCWS and IBS\u002FFD not related to wheat ingestion among CD patient's relatives (parents, grandparents, siblings and sons).",[117,288,29,119],"IBS (Irritable Bowel Syndrome)",[290,66,291,292,293],"non celiac wheat sensitivity","functional dyspepsia","celiac disease","Relatives","2026-05-07",{"date":296,"type":35},"2026-05-13",{"date":298,"type":35},"2026-04-01",{"date":300,"type":23},"2028-04-30",{"name":131,"class":42},{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":310,"targetDuration":4,"studyType":24,"phases":312,"briefSummary":313,"conditions":314,"keywords":317,"overallStatus":197,"whyStopped":4,"lastUpdateSubmitDate":327,"lastUpdatePostDateStruct":328,"startDateStruct":329,"completionDateStruct":331,"leadSponsor":333,"locationsCount":4},"100640497","cognitive-behavioral-therapy-for-functional-dyspepsia-epigastric-pain-syndrome-and-postprandial-distress-syndrome-subtypes-100640497","NCT07577089","Cognitive Behavioral Therapy for Functional Dyspepsia (Epigastric Pain Syndrome and Postprandial Distress Syndrome Subtypes)","Multimodal Phenotyping of Functional Dyspepsia: Controlled Trial on Response to Cognitive-Behavioral Therapy in Subtypes of Epigastric Pain Syndrome and Postprandial Discomfort Syndrome","FD-CBT","Inclusion Criteria:\n\n* Age 18-65 years\n* Diagnosis of Functional Dyspepsia according to Rome IV criteria\n* Classification as Epigastric Pain Syndrome (EPS) or Postprandial Distress Syndrome (PDS)\n* Active symptoms within the last month\n* Willingness to participate in Cognitive Behavioral Therapy and provide biological samples for research\n* Ability to provide written informed consent\n\nExclusion Criteria:\n\n* Presence of structural gastrointestinal disease (e.g., peptic ulcer, malignancy)\n* History of major abdominal surgery affecting the stomach or small intestine\n* Severe psychiatric disorders (e.g., psychosis, bipolar disorder) interfering with participation\n* Current participation in other interventional clinical trials\n* Use of medications that may confound study outcomes (e.g., chronic corticosteroids, immunosuppressants)\n* Pregnancy or breastfeeding",{"count":311,"type":23},90,[26],"The goal of this clinical trial is to learn whether adding Cognitive Behavioral Therapy (CBT) to standard medical treatment can improve symptoms in adults with Functional Dyspepsia. The study includes adults aged 18 to 65 years diagnosed with Functional Dyspepsia, classified as Epigastric Pain Syndrome or Postprandial Distress Syndrome.\n\nThe main questions it aims to answer are:\n\nDoes Cognitive Behavioral Therapy added to standard treatment reduce gastrointestinal symptoms compared with standard treatment alone? Do patients with Postprandial Distress Syndrome and Epigastric Pain Syndrome respond differently to Cognitive Behavioral Therapy? Researchers will compare optimized standard medical treatment alone to optimized standard treatment combined with Cognitive Behavioral Therapy to see if the addition of CBT leads to greater symptom improvement and better quality of life.\n\nParticipants will:\n\nBe randomly assigned to receive either standard medical treatment alone or standard treatment plus Cognitive Behavioral Therapy Take part in clinical visits and complete questionnaires about gastrointestinal symptoms, psychological well-being, and quality of life Provide blood, saliva, and stool samples at several time points over a 12-month follow-up period",[29,315,316],"Epigastric Pain Syndrome","Postprandial Distress Syndrome",[29,318,315,316,319,320,321,322,323,324,325,326],"Cognitive Behavioral Therapy","Gut-Brain Axis","Microbiota","Randomized Controlled Trial","Disorders of Gut-Brain Interaction","Gastrointestinal Symptoms","Inflammation","Biomarkers","Precision Medicine","2026-05-05",{"date":270,"type":35},{"date":330,"type":23},"2026-04",{"date":332,"type":23},"2028-12",{"name":334,"class":42},"Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis",{"id":336,"slug":337,"hasResults":12,"nctId":338,"briefTitle":339,"officialTitle":339,"acronym":4,"eligibilityCriteria":340,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":341,"enrollmentInfo":342,"targetDuration":4,"studyType":24,"phases":343,"briefSummary":346,"conditions":347,"keywords":348,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":360,"lastUpdatePostDateStruct":361,"startDateStruct":362,"completionDateStruct":364,"leadSponsor":366,"locationsCount":43},"100593576","phase-2-effect-of-amitriptyline-and-trifluoperazine-on-patients-with-functional-dyspepsia-100593576","NCT07008235","Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia","Inclusion Criteria:\n\n* Age 18 years or more\n* Patients with symptoms of dyspepsia for duration consisted with ROME IV criteria\n* Patients who are willing to sign informed written consent\n\nExclusion Criteria:\n\n* Structural lesion in Upper GI endoscopy and\u002For positive CLO test\n* Patients scoring 1 or 2 on the 5-point Likert scale for all four dyspepsia symptoms\n* History of malignancy, significant liver and biliary tract disease, hypertension, diabetes mellitus, chronic kidney disease, thyroid disorder, major psychiatric disorders\n* Previous history of gastrointestinal surgery\n* Patients those have to take any drug for other medical condition that may cause dyspepsia, can interfere or whose co-prescription is contraindicated with amitriptyline or trifluoperazine\n* Any patient with ongoing treatment with antidepressants or antipsychotics\n* Any history of hypersensitivity, adverse effect, or ineffectiveness with amitriptyline or trifluoperazine\n* Patients for whom Amitriptyline and Trifluoperazine are contraindicated\n* Elderly patients\\> 60 years\n* Pregnancy and breastfeeding","60 Years",{"count":183,"type":23},[344,345],"PHASE2","PHASE3","The goal of this clinical trial is to assess and compare the effect of amitriptyline and trifluoperazine in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drugs amitriptyline and trifluoperazine by recording the patient reported adverse events. The main questions it aims to answer are:\n\nDoes drug amitriptyline and trifluoperazine has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug amitriptyline and trifluoperazine? Researcher will compare drug amitriptyline and trifluoperazine to a control group taking standard first line treatment only.\n\nParticipants will:\n\nTake drug amitriptyline 10 milligrams at night or trifluoperazine 1 milligrams twice daily every day for 8 weeks along with standard first line treatment. A third group will be taken as control arm who will be kept on standard first line treatment only for 8 weeks. After that all three groups will be kept only on standard first line treatment for an additional 4 weeks. They will visit the hospital 4 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 4, 8, and 12. Additionally, patient reported adverse events will be documented.",[29],[29,349,350,351,352,353,354,355,356,357,358,359],"Amitriptyline","Trifluoperazine","Neuromodulator","DGBI","Disorders of Gut Brain Interaction","ROME IV","5-point Likert Scale","Tricyclic antidepressant","Phenothiazine","Antipsychotic","Dyspepsia","2026-05-04",{"date":294,"type":35},{"date":363,"type":35},"2025-07-01",{"date":365,"type":23},"2026-06",{"name":367,"class":42},"Md. Moktadirul Hoque Shuvo",{"id":369,"slug":370,"hasResults":12,"nctId":371,"briefTitle":372,"officialTitle":373,"acronym":4,"eligibilityCriteria":374,"healthyVolunteers":17,"sex":18,"minAge":139,"maxAge":4,"enrollmentInfo":375,"targetDuration":4,"studyType":24,"phases":377,"briefSummary":378,"conditions":379,"keywords":380,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":382,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":43},"100399536","clinical-trial-for-the-evaluation-of-the-efficacy-and-safety-of-edl-on-dyspepsia-100399536","NCT04482478","Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia","A 12 Week, Randomized, Double-blind, Placebo-Controlled Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia","Inclusion Criteria:\n\n1. Those over the age of 19\n2. Those diagnosed with functional dyspepsia (Rome IV\\*)\n\n   \\* One or more of the following symptoms are diagnosed when there is no organic cause in the test including the upper gastrointestinal endoscopy(if symptoms begin 6 months prior to Visit 1, and the symptoms are present in the past 3 months).\n   * Othersome postprandial fullness\n   * Unpleasant early satiation\n   * Unpleasant epigastric pain\n   * Unpleasant epigastric burning\n3. A person who has 4 or more of the 10 symptoms in the GIS (Gastrointestinal Symptom) questionnaire and has a total score of 12 or more (5-point Likert scale)\n4. When there is no organic disease in the gastroscopy performed at Visit 1 (however, it can be replaced by the test results within 3 months from Visit 1)\n5. A person who consented to participate in this clinical trial and signed a Informed consent form before the trail began.\n\nExclusion Criteria:\n\n1. Persons who are currently being treated with severe cardiovascular system, immune system, respiratory system, hepatobiliary system, kidney and urinary system, nervous system, musculoskeletal system, mental, infectious diseases, and malignant tumors (however, considering the condition of the subjects, subjects can participate in the test according to investigator's judgment.)\n2. Persons with a history of peptic ulcer and reflux esophagitis within 6 months of Visit 1\n3. Those who have gastrointestinal surgery (except appendectomy and hemorrhoidectomy)\n4. Persons with a history of malignancy of the digestive system\n5. Those who have taken H2 receptor blockers, anticholinergic agents (muscarinic receptor antagonists), gastrin receptor antagonists, prostaglandin preparations, proton pump inhibitors, gastric mucosal protective agents, other drugs intended to treat gastritis, gastric health-related health functional food within 2 weeks of Visit 1\n6. Those who need to constantly take medications that can cause gastritis, such as adrenal cortical hormones, nonsteroidal anti-inflammatory drugs, and aspirin during the human application test {However, low-dose aspirin for cardiovascular disease prevention (100 mg\u002Fday or less) permit}\n7. In the Drinking Habit Questionnaire, those who had an average alcohol intake of 14 units or more for men and or more 7 units for women per week for the past month.\n8. Uncontrolled hypertension persons (systolic blood pressure of 160 mmHg or higher, or diastolic blood pressure of 100 mmHg or higher, measurement criteria after 10 minutes of stability in human subjects)\n9. Persons with uncontrolled diabetes (fasting blood sugar is over 180 mg\u002FdL)\n10. Those whose Creatinine is more than twice the normal upper limit of the study institution\n11. Those whose AST(GOT) or ALT(GPT) is more than 3 times the normal upper limit of the study institution\n12. Persons who are sensitive or allergic to investigational product for this clinical trial\n13. Pregnant, lactating or planning to become pregnant within 3 months\n14. Those who participated in other clinical trials within 3 months of Visit 1 or plan to participate in other clinical trials after the start of this clinical trials.\n15. A person who determines that the Investigator is inappropriate for clinical trials\n16. Employee of Department of Digestive Internal Medicine, Seoul National University Bundang Hospital",{"count":376,"type":23},100,[26],"This clinical trial was designed to evaluate the functional and safety effects on dyspeptic symptoms compared to the placebo when ingested with EDL (Extract of Dolichos lablab Linne) in adults who complain of dyspeptic symptoms.",[29],[29,381],"GSRS","2026-04-23",{"date":384,"type":35},"2026-04-28",{"date":386,"type":35},"2020-07-01",{"date":388,"type":23},"2026-12-30",{"name":390,"class":42},"Seoul National University Bundang Hospital",{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":398,"targetDuration":4,"studyType":84,"phases":4,"briefSummary":399,"conditions":400,"keywords":401,"overallStatus":197,"whyStopped":4,"lastUpdateSubmitDate":414,"lastUpdatePostDateStruct":415,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":43},"100634389","psychoemotional-status-and-functional-gastrointestinal-disorders-100634389","NCT07539051","Psychoemotional Status and Functional Gastrointestinal Disorders","Assessment of the Influence of Psychoemotional Status on the Clinical Course of Functional Disorders of the Stomach and Intestine","Inclusion Criteria:\n\n* Age 18 years and older\n* Diagnosis of irritable bowel syndrome and\u002For functional dyspepsia according to Rome IV criteria\n* Written informed consent for participation in the study\n\nExclusion Criteria:\n\n* Age younger than 18 years\n* Clinical presentation not meeting Rome IV criteria\n* Inflammatory bowel disease\n* Pregnancy or lactation\n* Malignant neoplasms of any localization\n* History of gastrointestinal surgery",{"count":22,"type":23},"This prospective cohort study will evaluate the influence of psychoemotional status on the clinical course and quality of life of adult patients with functional dyspepsia and\u002For irritable bowel syndrome diagnosed according to Rome IV criteria. The study aims to assess the contribution of affective and somatoform disorders to quality of life and symptom burden in these patients. In participants with functional dyspepsia, the association of Helicobacter pylori status with psychoemotional status and quality of life will also be evaluated. Patients will complete validated questionnaires assessing quality of life, depression, anxiety, and somatization at baseline and again during follow-up after treatment. Clinical symptoms, pain severity, stool characteristics, and H. pylori status will also be assessed as applicable.",[29,118],[402,403,404,405,406,407,408,409,410,411,412,413],"Psychoemotional Status","Quality of Life","Anxiety","Depression","Somatization","PHQ-9","GAD-7","PHQ-15","SF-36","Helicobacter pylori","Rome IV","Gut-Brain Interaction","2026-04-13",{"date":416,"type":35},"2026-04-20",{"date":418,"type":23},"2026-05-01",{"date":420,"type":23},"2028-05-01",{"name":422,"class":42},"Center of New Medical Technologies",{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":430,"enrollmentInfo":431,"targetDuration":4,"studyType":24,"phases":433,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":197,"whyStopped":4,"lastUpdateSubmitDate":441,"lastUpdatePostDateStruct":442,"startDateStruct":444,"completionDateStruct":446,"leadSponsor":448,"locationsCount":450},"100631123","efficacy-evaluation-of-electroacupuncture-in-the-treatment-of-functional-dyspepsia-100631123","NCT07496580","Efficacy Evaluation of Electroacupuncture in the Treatment of Functional Dyspepsia","Efficacy Evaluation of Electroacupuncture in the Treatment of Functional Dyspepsia: A Multicenter Clinical Trial Study","Inclusion Criteria:\n\n* Participants who meet the Rome IV diagnostic criteria for functional dyspepsia (FD).\n* Age 18 to 80 years, male or female.\n* Chinese patients with a normal upper gastrointestinal endoscopy within the past 1 year, or judged by a gastroenterologist with more than 3 years of clinical experience to have no structural disease that explains the symptoms.\n* Willing and able to provide written informed consent and comply with study procedures.\n\nExclusion Criteria:\n\n* Functional dyspepsia symptoms caused by severe or malignant diseases (e.g., liver cirrhosis, heart failure, or gastrointestinal tumors).\n* Helicobacter pylori infection, defined as a positive urea breath test or positive Hp test on endoscopy.\n* History of gastrointestinal surgery (except minimally invasive procedures such as laparoscopy).\n* Presence of a permanent or temporary cardiac pacemaker or use of external\u002Ftemporary pacing support.\n* Use of medications that may affect dyspepsia symptoms within 2 weeks prior to enrollment, including antisecretory drugs, antacids, prokinetic agents, digestive enzymes, nonsteroidal anti-inflammatory drugs, antidepressants, or traditional Chinese medicine for FD.\n* Conditions that may make participation difficult, such as severe mental or physical illness, dementia, or illiteracy.\n* Severe coagulation disorders.\n* Acupuncture treatment for gastrointestinal diseases within the past 1 month.\n* Participation in another clinical trial within the past 2 months.\n* Drug abuse or alcohol abuse.\n* Pregnant or breastfeeding women.","80 Years",{"count":432,"type":23},105,[26],"Functional dyspepsia (FD) is a common disorder that causes stomach discomfort, such as fullness or pain after eating, without any visible structural disease. Acupuncture is often used to manage these symptoms. This study aims to evaluate the safety and effectiveness of electroacupuncture-a form of acupuncture that uses gentle electrical stimulation-for treating functional dyspepsia. Specifically, the trial will compare the benefits of applying electroacupuncture to points on the abdomen (local points) versus points on the arms and legs (distal points), alongside a control group receiving a sham (inactive) treatment. The goal is to determine the most effective acupuncture strategy for improving patients' digestive symptoms and overall quality of life.",[29,436],"Electroacupuncture",[291,438,439,440],"electroacupuncture","Local Acupoints","Distal Acupoints","2026-03-22",{"date":443,"type":35},"2026-03-27",{"date":445,"type":23},"2026-03-01",{"date":447,"type":23},"2027-12-31",{"name":449,"class":42},"The Third Affiliated hospital of Zhejiang Chinese Medical University",4,{"id":452,"slug":453,"hasResults":12,"nctId":454,"briefTitle":455,"officialTitle":456,"acronym":4,"eligibilityCriteria":457,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":458,"targetDuration":4,"studyType":24,"phases":460,"briefSummary":461,"conditions":462,"keywords":465,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":471,"lastUpdatePostDateStruct":472,"startDateStruct":474,"completionDateStruct":476,"leadSponsor":478,"locationsCount":43},"100626984","auricular-stimulation-for-functional-dyspepsia-with-insomnia-efficacy-and-mechanisms-100626984","NCT07442734","Auricular Stimulation for Functional Dyspepsia With Insomnia: Efficacy and Mechanisms","Study on the Efficacy and Mechanism of Auricular Stimulation for Functional Dyspepsia With Insomnia Based on Brain Function: A Single-center, Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Meet the diagnostic criteria for functional dyspepsia and sleep disorders (25,26)\n* Pittsburgh Sleep Quality Index score ≥7\n* Right-handed, aged 18 years or above\n* Have not taken the following medications for at least 2 weeks prior to enrollment: antibiotics (oral, intramuscular, or intravenous), microbiota-related products (probiotics, prebiotics, and synbiotics, etc.), or any drugs affecting gastrointestinal flora, any drugs or supplements that improve sleep quality or suppress neural activity in the brain, medications related to functional dyspepsia treatment, or other related therapies\n* Agree to voluntarily participate in this study and sign the informed consent form\n\nExclusion Criteria:\n\n1. Secondary insomnia caused by drugs or other diseases\n2. Comorbidity with other psychiatric disorders, or severe heart, liver, kidney, or other systemic diseases\n3. Previously received this treatment method or participated in other clinical trials within the past 6 months\n4. Presence of contraindications to auricular therapy, such as allergy to skin preparation or damage at the auricular application site\n5. Pregnant or breastfeeding women\n6. History of cranial organic lesions, cranial surgery, or severe trauma",{"count":459,"type":23},176,[26],"Functional dyspepsia (FD) is a chronic disorder of gut-brain interaction characterized by bothersome upper abdominal symptoms arising from the gastroduodenal region. Diagnosis is made after clinical evaluation has excluded structural disease that could explain symptoms (e.g., upper gastrointestinal endoscopy). According to Rome IV criteria, FD is categorized into postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS), with symptom overlap commonly observed. FD is prevalent worldwide and is associated with substantial impairment in health-related quality of life and a significant socioeconomic burden.\n\nSleep disturbance, anxiety, and depression are frequent in FD and are associated with symptom severity and recurrence. Current management-such as prokinetic agents, acid-suppressive therapy, and psychotropic medications when indicated-can be limited by variable efficacy, adverse effects, and concerns regarding long-term use. The pathophysiology of FD is multifactorial and incompletely understood; increasing evidence highlights dysregulation of the brain-gut axis and autonomic nervous system function (12,13). Auricular vagus nerve-related stimulation may influence brainstem neurotransmission, gastric tone\u002Fmotility, and mood (14), suggesting a potentially safe, non-pharmacological approach for FD with comorbid sleep problems. However, the mechanistic links among autonomic regulation, gut microbiota\u002Fshort-chain fatty acids, and FD remain uncertain.\n\nThis study aims to evaluate the clinical efficacy and safety of auricular acupoint stimulation in FD patients with sleep disorders and to explore underlying mechanisms using brain-function assessments together with autonomic and gastrointestinal-related measures.",[29,463,464],"Insomnia","Brain and Nervous System",[466,29,467,468,469,470],"Auricular Acupressure","insomnia","clinical efficacy","Effect mechanism study","Brain functional areas","2026-02-24",{"date":473,"type":35},"2026-03-02",{"date":475,"type":35},"2025-10-30",{"date":477,"type":23},"2026-10-01",{"name":479,"class":42},"The First Affiliated Hospital of Zhejiang Chinese Medical University",{"id":481,"slug":482,"hasResults":12,"nctId":483,"briefTitle":484,"officialTitle":485,"acronym":4,"eligibilityCriteria":486,"healthyVolunteers":17,"sex":487,"minAge":488,"maxAge":19,"enrollmentInfo":489,"targetDuration":4,"studyType":24,"phases":490,"briefSummary":491,"conditions":492,"keywords":495,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":500,"lastUpdatePostDateStruct":501,"startDateStruct":503,"completionDateStruct":505,"leadSponsor":507,"locationsCount":43},"100582430","autonomic-reactivity-and-personalized-neurostimulation-100582430","NCT06863207","Autonomic Reactivity and Personalized Neurostimulation","Autonomic Reactivity to Restore a Dysregulated Brain-Gut Axis Via Targeted Therapy","Inclusion Criteria:\n\n* 11 to 18 years of age\n* English speaking\n* meeting Rome IV diagnostic criteria for cyclic vomiting syndrome or functional dyspepsia and willingness to participate and consent\u002Fassent to the study\n* All subjects will have a constellation of chronic symptoms indicative of autonomic dysfunction for minimum 3 months: postural dizziness\u002Flightheadedness, syncope, palpitations, fatigue, sleep disturbance, thermoregulatory abnormalities and cognitive impairment with upright position +\u002F- abnormal autonomic testing if performed per standard of care as per American Autonomic Society consensus criteria.\n\nExclusion Criteria:\n\n* Presence of organic disease that may explain symptoms\n* Requirement for parenteral nutrition\n* Developmental delays precluding accurate symptom report\n* Severe dermatological condition or active infection of external or middle ear\n* Implanted electrical device\n* Severe mental health disorder not controlled by therapy (schizophrenia, bipolar disease, severe depression, post-traumatic distress disorder) and\u002For psychotic features which could influence symptom report or ANS measurements and result in adverse reactions to hypnosis therapy","FEMALE","11 Years",{"count":183,"type":23},[26],"Disorders of gut-brain interaction (DGBI) affect up to 25% of U.S. children. Patients often suffer from disabling, multisystem comorbidities that suggest a common root (sleep disturbances, fatigue, anxiety, etc). Yet, DGBI are defined and treated based on GI symptom origin (cyclic vomiting, dyspepsia, irritable bowel) rather than underlying pathophysiology. Many patients manifest comorbidities suggesting an underlying autonomic nervous system (ANS) dysregulation (palpitations, dizziness, cognitive dysfunction). Unfortunately, due to common features of anxiety and visceral hyperreactivity and lack of obvious pathology, children with DGBI are frequently diagnosed with psychosomatic or 'benign, functional disorders' and treated with empiric antidepressants despite lack of scientific support and risks of serious side effects. Little is known about the underlying brain-gut mechanisms linking these comorbidities. A lack of targeted treatment options naturally follows the paucity of mechanistic data. A dysregulated ANS response circuit via brainstem nuclei is linked to visceral hypersensitivity. As the team's prior research has shown, ANS regulation can be non-invasively measured via several validated indices of cardiac vagal tone. Using the novel vagal efficiency (VE) metric, the investigators have demonstrated inefficient vagal regulation in cyclic vomiting syndrome and pain-related DGBI and that low VE predicts response to non-invasive, auricular percutaneous electrical nerve field stimulation (PENFS) therapy. PENFS targets brainstem vagal afferent pathways and, along with brain-gut interventions such as hypnotherapy, are the only therapies currently proven effective for pediatric DGBI. Individualizing neurostimulation based on sensory thresholds while assessing dynamic ANS reactivity offers a path towards personalized medicine using the most effective therapies to date. This proposal will test the feasibility of an ANS tracking software in assessing real-time, autonomic regulation and providing individualized neurostimulation in children with nausea\u002Fvomiting and ANS imbalance.",[60,493,29,494],"Cyclic Vomiting Syndrome","Dysautonomia",[496,497,498,499],"autonomic dysfunction","auricular neurostimulation","gastric motor function","gut-directed hypnotherapy","2026-02-11",{"date":502,"type":35},"2026-02-13",{"date":504,"type":35},"2025-01-24",{"date":506,"type":23},"2029-06",{"name":508,"class":42},"Medical College of Wisconsin",{"id":510,"slug":511,"hasResults":12,"nctId":512,"briefTitle":513,"officialTitle":514,"acronym":4,"eligibilityCriteria":515,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":140,"enrollmentInfo":516,"targetDuration":4,"studyType":24,"phases":518,"briefSummary":519,"conditions":520,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":521,"lastUpdatePostDateStruct":522,"startDateStruct":524,"completionDateStruct":526,"leadSponsor":527,"locationsCount":43},"100503541","functional-dyspepsia-treatment-using-virtual-reality-100503541","NCT05836597","Functional Dyspepsia Treatment Using Virtual Reality","Effectiveness and Safety of Virtual Reality for the Treatment of Functional Dyspepsia","Inclusion Criteria:\n\n* Symptoms of dyspepsia thought to represent functional dyspepsia, meeting Rome IV criteria\n* Had an upper endoscopy and assessment for Helicobacter pylori; if a patient is found to have H. pylori, treatment with confirmed eradication (by stool antigen test or urea breath test) will be required before the patient is eligible for study inclusion.\n* Patients will be considered for the study if they have undergone a complete history and physical examination during a previously scheduled consultation\u002Fevaluation visit with a gastroenterologist in the Mayo Clinic Florida General GI or Motility clinic.\n\nExclusion Criteria:\n\n* Symptoms are thought to represent an organic disorder (e.g., peptic ulcer disease, hepatitis, pancreatitis, inflammatory bowel disease, type I diabetes, a known malignancy, radiation-induced injury, an active infection, vasculitis, celiac disease), or patients have known uncontrolled GERD, esophagitis, eosinophilic esophagitis, or untreated H. pylori.\n* Patients with gastroparesis or cyclic vomiting syndrome.\n* Patients with prior surgery to the esophagus, stomach or duodenum.\n* Patients taking opioids.\n* Patients with motion sickness, vertigo, or a seizure disorder\n* IBS symptoms are not predominant.",{"count":517,"type":23},30,[26],"The purpose of this study is to evaluate the effectiveness of using virtual reality to treat gastrointestinal symptoms related to functional dyspepsia.",[29],"2026-01-21",{"date":523,"type":35},"2026-01-22",{"date":525,"type":35},"2024-04-01",{"date":224,"type":23},{"name":528,"class":42},"Mayo Clinic",{"id":530,"slug":531,"hasResults":12,"nctId":532,"briefTitle":533,"officialTitle":534,"acronym":535,"eligibilityCriteria":536,"healthyVolunteers":12,"sex":18,"minAge":537,"maxAge":538,"enrollmentInfo":539,"targetDuration":4,"studyType":24,"phases":541,"briefSummary":542,"conditions":543,"keywords":544,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":43},"100246267","phase-3-ketotifen-for-children-with-functional-dyspepsia-in-association-with-duodenal-eosinophilia-100246267","NCT02484248","Ketotifen for Children With Functional Dyspepsia in Association With Duodenal Eosinophilia","Double-blind, Placebo-controlled, Cross-over Trial of Ketotifen in Children and Adolescents With Functional Dyspepsia in Association With Duodenal Eosinophilia","Ketotifen","Inclusion Criteria:\n\n1. between the ages of 8 and 17 years, inclusive\n2. abdominal pain of at least 8 weeks duration and fulfilling symptom-based criteria for functional dyspepsia(5);\n3. previous endoscopy with biopsies demonstrating \\>20 eosinophils\u002Fhigh powered field on duodenal mucosal biopsies;\n4. previous treatment with acid-reduction therapy and montelukast with a level 3 (as defined below)or lesser response;\n5. evidence of written parental permission (consent) and subject assent;\n6. Negative pregnancy screening for females of child bearing potential.\n\nExclusion Criteria:\n\n1. previous treatment with ketotifen;\n2. treatment with oral corticosteroids or oral cromolyn sodium in the 6 months prior to enrollment;\n3. any prior history of diabetes mellitus, cancer, chronic cardiac disease, respiratory disease, or renal disease requiring routine medical care;\n4. Pregnant\u002Fplanning to become pregnant;\n5. Post-menarche females unwilling to use highly-efficacious contraception to prevent pregnancy;\n6. Epilepsy or history of seizures;\n7. Liver disease or elevation of liver enzymes;\n8. Use of oral hypoglycemic medications, antipsychotics, benzodiazepines, tricyclic antidepressants, barbiturates, or opioids;\n9. Allergy to ketotifen or other products in capsule\n10. Refusal of Urine pregnancy test in post-menarchal females.","8 Years","17 Years",{"count":540,"type":23},40,[345],"Acid reduction remains the most common treatment prescribed empirically by pediatric gastroenterologists for children with functional dyspepsia (FD). When acid reduction therapy fails to provide patients with a therapeutic effect, ketotifen and cromolyn, mast cell stabilizers, represent an attractive potential therapy given data implicating mast cells in the generation of dyspeptic symptoms. Although there have been no adult or pediatric studies on the use of mast cell stabilizers in patients with FD, benefit has been demonstrated in adults with IBS and children with eosinophilic gastroenteritis. Additionally, previous studies show mucosal eosinophilia is highly correlated with functional dyspepsia. Our usual current treatment pathway for functional dyspepsia in association with duodenal mucosal eosinophilia is as follows: acid-reducing medication\u002Fmontelukast → addition of H1 antagonist → addition of budesonide → addition of oral cromolyn. If ketotifen is effective, it offers the advantage of being able to replace both the H1 antagonist and the oral cromolyn at a substantially reduced cost (approximately 10% of the cost of cromolyn alone). This study aims to introduce ketotifen earlier in the treatment pathway to examine its efficacy on children with functional dyspepsia in association with duodenal eosinophilia.",[29],[545,546,547,548,291],"pediatric","eosinophilia","duodenal","ketotifen","2026-01-08",{"date":551,"type":35},"2026-01-09",{"date":553,"type":35},"2015-08",{"date":555,"type":23},"2027-04-01",{"name":557,"class":42},"Craig A. Friesen, MD",{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":566,"targetDuration":4,"studyType":24,"phases":567,"briefSummary":568,"conditions":569,"keywords":4,"overallStatus":197,"whyStopped":4,"lastUpdateSubmitDate":570,"lastUpdatePostDateStruct":571,"startDateStruct":572,"completionDateStruct":574,"leadSponsor":575,"locationsCount":4},"100614162","probiotics-in-functional-dyspepsia-100614162","NCT07276009","Probiotics in Functional Dyspepsia","The Effect of Multi-strain Probiotic Formulation on Gastrointestinal Symptoms, Quality of Life and Mental Health in Patients With Functional Dyspepsia: a Randomized Dietary Trial","ProPepsis","Inclusion Criteria:\n\n1. Age 18-65 years\n2. Diagnosis of Functional Dyspepsia based on Rome IV criteria, with symptoms present for at least 3 months, and symptom onset at least 6 months before diagnosis, including:\n\n   * Postprandial fullness\n   * Early satiation\n   * Epigastric pain or burning\n   * (with no evidence of structural disease explaining symptoms)\n3. Moderate to severe symptom severity at baseline, as defined by a validated scale (e.g., NDI or global symptom score)\n4. Normal upper GI endoscopy within the last 12 months (or at screening), excluding structural disease (e.g., peptic ulcer, malignancy)\n5. Negative for H. pylori (either previously treated successfully or tested negative within study screening)\n6. Ability and willingness to provide informed consent and comply with study procedures\n7. Stable medication use, if any, for at least 4 weeks before screening (e.g., PPIs, antidepressants, laxatives)\n\nExclusion Criteria:\n\n1. Evidence of structural GI disease (e.g., peptic ulcer, gastric cancer, celiac disease) on recent or screening endoscopy\n2. History of gastrointestinal surgery affecting stomach or small intestine (except appendectomy or cholecystectomy)\n3. Positive test for H. pylori during screening (or untreated known infection)\n4. Current or recent use (within 4 weeks) of antibiotics, pre-, pro- or postbiotics, unless part of study protocol\n5. Use of medications affecting GI motility (e.g., prokinetics, opioids, anticholinergics) within 2-4 weeks before enrollment\n6. Overlap with other functional GI disorders (except IBS) if they are the dominant complaint, unless your protocol allows overlap\n7. Clinically significant psychiatric illness (e.g., major depression, schizophrenia) that may interfere with symptom reporting or adherence\n8. Severe systemic or metabolic disease (e.g., uncontrolled diabetes, renal or hepatic failure)\n9. Pregnancy or lactation, or intention to become pregnant during the study period\n10. Participation in another clinical trial within the past 3 months\n11. Known allergy or intolerance to study product components",{"count":260,"type":23},[26],"The goal of this clinical trial is to learn whether a multi-strain probiotic can reduce digestive symptoms and improve quality of life in adults with functional dyspepsia. The main questions it aims to answer are:\n\n* Does the probiotic reduce symptoms such as fullness after meals, bloating, stomach discomfort, and early satiation?\n* Does the probiotic improve emotional well-being, including stress, anxiety, and mood? Researchers will compare the probiotic to a placebo (a look-alike capsule with no active ingredients) to see if the probiotic truly helps adults with functional dyspepsia.\n\nParticipants will:\n\n* Take one capsule of the probiotic or placebo once daily before meals for 60 days\n* Complete questionnaires about their digestive symptoms at the start, 1 month, and 2 months\n* Complete surveys on stress, anxiety, depression, and quality of life at the start and 2 months\n* Attend scheduled study visits for checkups and assessments",[29],"2026-01-07",{"date":549,"type":35},{"date":573,"type":23},"2026-01-05",{"date":418,"type":23},{"name":576,"class":154},"Nordic Biotic Sp. z o.o.",{"id":578,"slug":579,"hasResults":12,"nctId":580,"briefTitle":581,"officialTitle":582,"acronym":583,"eligibilityCriteria":584,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":585,"targetDuration":4,"studyType":24,"phases":587,"briefSummary":588,"conditions":589,"keywords":590,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":573,"lastUpdatePostDateStruct":599,"startDateStruct":600,"completionDateStruct":602,"leadSponsor":604,"locationsCount":43},"100609309","probiotic-and-ginger-supplement-for-symptoms-and-quality-of-life-in-functional-dyspepsia-subtile-100609309","NCT07212907","Probiotic and Ginger Supplement for Symptoms and Quality of Life in Functional Dyspepsia (SUBTILE)","Effect of a Combination of Spore-forming Probiotics (Bacillus Coagulans MY01 and Bacillus Subtilis MY02) and Ginger Extract on Symptoms and Quality of Life in Patients With Functional Dyspepsia","SUBTILE","Inclusion Criteria:\n\n* Adults (male or female) aged ≥18 years.\n* Diagnosis of functional dyspepsia (FD) according to Rome IV criteria, with normal upper endoscopy including negative Helicobacter pylori test. Rome IV criteria define FD as the presence of one or more of the following symptoms: bothersome postprandial fullness, early satiety, epigastric pain, or epigastric burning, occurring at least 3 days per week during the last 3 months, with symptom onset at least 6 months prior to diagnosis.\n* PAGI-SYM total score \\>1 at baseline.\n* Ability to comply with study requirements and provide signed written informed consent before any study-related procedures.\n* Ability to complete the patient diary and questionnaires, in the investigator's opinion (sufficient reading and language comprehension).\n* For women of childbearing potential : Negative urine pregnancy test immediately before starting study product ; Agreement to use an approved method of contraception for the duration of the study, unless meeting criteria for menopause (≥12 months of spontaneous amenorrhea). Women of childbearing potential are defined as all women physiologically capable of becoming pregnant, including those whose career, lifestyle, or sexual orientation normally precludes heterosexual intercourse.\n* Affiliation with a national health insurance or social security system.\n\nExclusion Criteria:\n\n* Use within 2 weeks prior to baseline of treatments that could interfere with study evaluation, including Bacillus coagulans MY01, Bacillus subtilis MY02, ginger, peppermint, or antibiotics.\n* Known allergy or hypersensitivity to any component of the investigational product.\n* Contraindication or specific warning related to the investigational product, including use of anticoagulants.\n* Use of immunosuppressive therapy within the last 3 months.\n* Use of medications affecting gastrointestinal motility or sensitivity, including opioids, GLP-1 analogs, neuroleptics, antiemetics, or anticholinergics. (Stable antidepressant therapy allowed.)\n* Significant changes in diet or physical activity within 2 weeks prior to baseline or anticipated during the study period.\n* Active somatic or psychiatric disorder that could explain dyspeptic symptoms (e.g., active cancer, inflammatory disease). Stable use of one antidepressant is allowed for psychiatric indication.\n* Active Helicobacter pylori infection.\n* Predominant symptoms of gastroesophageal reflux disease (GERD) or irritable bowel syndrome (IBS).\n* Functional diarrhea or functional constipation as defined by Rome IV criteria.\n* History of abdominal surgery within the past year, except appendectomy, cholecystectomy, inguinal hernia repair, or splenectomy.\n* Pregnant or breastfeeding women.\n* Individuals under legal guardianship or curatorship.\n* Participation in another interventional clinical trial and receipt of an investigational product within 30 days prior to baseline.\n* Any acute or chronic medical or psychiatric condition that, in the investigator's judgment, could interfere with study assessments, including but not limited to severe hepatic or renal insufficiency, immunodeficiency, or substance abuse (alcohol or drugs).\n* Any personal condition or circumstance that, in the investigator's judgment, would make full participation in the study unlikely or impossible.",{"count":586,"type":23},198,[26],"Functional dyspepsia (FD) is a frequent functional gastrointestinal disorder characterized by bothersome postprandial fullness, early satiety, epigastric pain, or burning, in the absence of any structural or metabolic cause. It significantly impairs quality of life and has limited therapeutic options, as conventional treatments such as proton pump inhibitors often show modest efficacy and may cause side effects with long-term use.\n\nThe gut and duodenal microbiota may play a role in FD. Spore-forming probiotics such as Bacillus coagulans MY01 and Bacillus subtilis MY02 have shown beneficial effects on FD symptoms in a randomized controlled trial. Ginger (Zingiber officinale) has a long history of traditional use as a gastroprotective agent and is supported by clinical and non-clinical data for improving gastric motility and related symptoms.\n\nThis study (SUBTILE, STO-253) is a prospective, interventional, multicenter trial conducted in France. It will evaluate the effect of a dietary supplement containing Bacillus coagulans MY01, Bacillus subtilis MY02, and ginger extract (50 mg, 20% gingerols) on FD symptoms and quality of life.\n\nA total of 198 adult patients diagnosed with FD according to Rome IV criteria and with a normal upper endoscopy will be recruited in primary care and gastroenterology practices. Participants will take one capsule of the study product daily for 8 weeks.\n\nThe primary outcome is the change in the Patient Assessment of Gastrointestinal Symptom Severity (PAGI-SYM) total score between baseline and Week 8.\n\nSecondary outcomes include changes in quality of life (PAGI-QoL), treatment adherence, use of concomitant medications, evolution of lower gastrointestinal symptoms, patient and physician global impressions of change (PGI-C, CGI-I), and satisfaction (Likert scales). An exploratory objective will assess psychological impact using the Hospital Anxiety and Depression Scale (HADS).\n\nThe study includes two site visits (baseline and end of study) and one telephone follow-up at Day 28. Safety and tolerability will be monitored through active reporting of adverse events.\n\nThe trial aims to provide new evidence on the role of probiotics combined with ginger extract as a non-pharmacological strategy to improve digestive comfort and quality of life in patients with functional dyspepsia.",[29],[29,591,592,593,594,595,596,597,598,315],"Bacillus coagulans MY01","Bacillus subtilis MY02","Ginger extract","Symbiosys Stomalex","Gut microbiota","Quality of life","Gastrointestinal symptoms","Spore-forming probiotics",{"date":570,"type":35},{"date":601,"type":35},"2025-12-22",{"date":603,"type":23},"2027-01",{"name":605,"class":154},"Biocodex",{"id":607,"slug":608,"hasResults":12,"nctId":609,"briefTitle":610,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":430,"enrollmentInfo":613,"targetDuration":4,"studyType":24,"phases":615,"briefSummary":616,"conditions":617,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":620,"startDateStruct":621,"completionDateStruct":623,"leadSponsor":625,"locationsCount":43},"100607356","phase-4-efficacy-of-bacillus-coagulans-in-alleviating-anxiety-and-depression-in-patients-with-functional-dyspepsia-100607356","NCT07187492","Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia","Efficacy of Bacillus Coagulans in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia：A Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Trial","Inclusion Criteria:\n\n* Patients diagnosed with functional dyspepsia (FD) according to the Rome IV criteria.\n* Aged 18 to 80 years, regardless of gender.\n* Hospital Anxiety and Depression Scale (HADS) score between 8 and 14.\n\nExclusion Criteria:\n\n* Use of probiotics or antibiotics within one month prior to the trial.\n* Use of psychoactive medications (including hypnotics, sedatives, anxiolytics, or antidepressants) within one month prior to the trial.\n* Use of hormones, immunosuppressants, or cytotoxic agents within one month prior to the trial.\n* Participation in any other clinical trial within one month prior to the study.\n* Positive test for Helicobacter pylori (Hp) infection.\n* Long-term use of traditional Chinese herbal medicine.\n* Pregnancy or lactation.\n* History of drug abuse.\n* Comorbidities such as irritable bowel syndrome (IBS), gastroesophageal reflux disease (GERD), functional constipation (FC), or other significant conditions that may interfere with the trial-including severe hepatic, renal, respiratory, or autoimmune disorders; bleeding diatheses; psychiatric diseases; endocrine disorders; etc.\n* History of major surgery or diagnosis of diabetes mellitus.\n* Refusal to provide written informed consent.",{"count":614,"type":23},180,[144],"Objective: This study aims to evaluate the effectiveness of Bacillus coagulans in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria.\n\nMethods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Bacillus coagulans, while the control group received a placebo with the same appearance and odor.\n\nThe treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.",[29,618,405,404],"Probiotics","2025-12-29",{"date":573,"type":35},{"date":622,"type":35},"2025-09-20",{"date":624,"type":23},"2027-05-31",{"name":626,"class":42},"Xijing Hospital of Digestive Diseases",{"id":628,"slug":629,"hasResults":12,"nctId":630,"briefTitle":631,"officialTitle":632,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":430,"enrollmentInfo":633,"targetDuration":4,"studyType":24,"phases":634,"briefSummary":635,"conditions":636,"keywords":4,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":619,"lastUpdatePostDateStruct":637,"startDateStruct":638,"completionDateStruct":639,"leadSponsor":640,"locationsCount":43},"100607002","phase-4-efficacy-of-clostridium-butyricum-in-alleviating-anxiety-and-depression-in-patients-with-functional-dyspepsia-100607002","NCT07182890","Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia","Efficacy of Clostridium Butyricum in Alleviating Anxiety and Depression in Patients With Functional Dyspepsia：A Prospective, Double-Blind, Randomized, Placebo-Controlled Clinical Trial",{"count":614,"type":23},[144],"Objective: This study aims to evaluate the effectiveness of Clostridium butyricum in improving anxiety and depression in patients diagnosed with functional dyspepsia according to the Rome IV criteria.\n\nMethods: This trial plans to enroll 180 patients (90 per group). The study will employ a double-blind design. For patients diagnosed with FD according to the Rome IV criteria, in addition to conventional treatment (treated with Mosapride Citrate Tablets (Guangdong Anno Guocai) for Postmeal Discomfort Syndrome (PDS) and Esomeprazole Enteric Coated Tablets (Shijiazhuang Longze Pharmaceutical Guocai) for Upper Abdominal Pain Syndrome (EPS)), the experimental group was treated with Clostridium butyricum, while the control group received a placebo with the same appearance and odor.\n\nThe treatment intervention will last for 4 weeks. The main indicator of this experiment is the improvement of the Hospital Anxiety and Depression Scale (HADS score) after 4 weeks of treatment. The secondary indicators are the improvement rate of the overall treatment effectiveness evaluation questionnaire (OTE questionnaire), the improvement of the global overall symptom score (GOS score), the improvement of the simplified Nipin scale (SF-NDI), and the improvement of the Pittsburgh Sleep Index (PSQI) after 4 weeks of treatment. Upon completion of the trial, the patients' conditions will be re-evaluated, and treatment plans will be adjusted accordingly.",[29,618,405,404],{"date":573,"type":35},{"date":622,"type":35},{"date":624,"type":23},{"name":626,"class":42},{"id":642,"slug":643,"hasResults":12,"nctId":644,"briefTitle":645,"officialTitle":646,"acronym":647,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":18,"minAge":537,"maxAge":538,"enrollmentInfo":649,"targetDuration":4,"studyType":24,"phases":651,"briefSummary":652,"conditions":653,"keywords":656,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":43},"100617473","pain-in-pediatric-patients---internet-interventions-for-disorders-of-gut-brain-interaction-100617473","NCT07319078","Pain in Pediatric Patients - Internet Interventions for Disorders of Gut-brain Interaction","Internet-delivered Psychological Interventions for Pediatric Disorders of Gut-brain Interaction - a Randomised Controlled Study","PIPPI","Inclusion Criteria:\n\n* Age 8-17 years\n* Basic somatic work-up completed (CRP\u002FESR, TGA, complete blood count, fecal calprotectin)\n* Confirmed DGBI diagnosis: IBS, functional abdominal pain, or functional dyspepsia (according to Rome IV criteria)\n* Any constipation must be treated according to current clinical guidelines, with stable laxative dosing for at least one month prior to referral\n* In cases of celiac disease, the participant must have followed a gluten-free diet for at least six months and TGA values must have normalized\n* For participants with a neuropsychiatric diagnosis treated with medication, at least two months must have passed since the last dose adjustment\n* At least one parent and the child\u002Fadolescent must be fluent in Swedish and willing to participate in both the educational program and treatment (regardless of randomization outcome), complete homework assignments, and respond to questionnaires\n\nExclusion Criteria:\n\n* Other organic disease that better explains the gastrointestinal symptoms\n* At referral assessment, psychiatric symptoms or psychosocial problems - such as severe bullying, high school absenteeism, or difficult family circumstances - are judged to be more prominent than the gastrointestinal problems and require more extensive, multiprofessional care than what the study can offer\n* Participants who have already completed gut-directed hypnotherapy or CBT",{"count":650,"type":23},200,[26],"Many children and adolescents often experience long-lasting stomach pain. In many cases, this is due to disorders of gut-brain interaction (DGBI), such as irritable bowel syndrome (IBS), functional abdominal pain, and functional dyspepsia. These conditions are caused by disrupted communication between the brain and the gut. They are linked to significant suffering, reduced quality of life, and higher school absenteeism. Psychological treatments such as cognitive behavioral therapy (CBT) have shown good effect, but waiting times within healthcare are often long. Therefore, there is a need for more accessible and cost-effective treatment alternatives.\n\nThe goal of this clinical trial is to explore whether gut-directed hypnotherapy, already used successfully in the Netherlands, can be implemented as a new treatment option in Swedish healthcare. In addition, the study will compare gut-directed hypnotherapy with internet-based CBT (iCBT) to learn which digital treatment works best for children and adolescents with DGBI.\n\nParticipants will:\n\nBe children or adolescents between 8 and 17 years old.\n\nFirst take part in a 4-week online education program called the \"gut-school,\" which explains the stomach, the brain, and how symptoms can be managed.\n\nIf symptoms remain after the gut-school, be randomly assigned to one of two digital treatments:\n\niCBT (internet-based cognitive behavioral therapy). 10 week long.\n\nGut-directed hypnotherapy, delivered as audio recordings to be used at home. 12 week long.\n\nAnswer online survey questions before, during, and after treatment so researchers can follow their progress.\n\nThese two treatments have never been directly compared. By comparing them, researchers hope to learn not only which treatment works best overall, but also which treatment is most suitable for different participants. The long-term aim is to make gut-directed hypnotherapy, already successful in the Netherlands, available as a treatment option in Sweden.",[654,655,29],"Irritable Bowel Disease","Functional Abdominal Pain - Not Otherwise Specified (FAP-NOS)",[499,657,658,659,660,66,661],"patient education","disorder of gut-brain intercation","cognitive behavioral therapy","functional abdominal pain","randomised controlled trial","2025-12-19",{"date":664,"type":35},"2026-01-06",{"date":666,"type":35},"2025-12-01",{"date":668,"type":23},"2030-03",{"name":670,"class":42},"Karolinska Institutet"]