[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"celiac-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:celiac-disease":28},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,38,0,25,[9,46,72,102,126,151,178,198,222,244,269,294,329,360,391,421,447,470,499,526,561,589,618,700,730],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100652762","effects-of-kefir-on-celiac-disease-100652762",false,"NCT07777666","Effects of Kefir on Celiac Disease","Effects of Kefir Consumption on Celiac Disease Symptoms","CeliKef","Inclusion Criteria:\n\n* Adults aged 18 years or older with a confirmed diagnosis of celiac disease.\n* Following a strict gluten-free diet.\n\nExclusion Criteria:\n\n* Other chronic gastrointestinal diseases.\n* Pregnancy.\n* Known allergy or intolerance to milk or dairy products or other components of kefir.","ALL","18 Years",{"count":21,"type":22},30,"ESTIMATED","INTERVENTIONAL",[25],"NA","This study will investigate whether regular consumption of kefir can reduce gastrointestinal symptoms and improve quality of life in adults with celiac disease who follow a strict gluten-free diet. The study will use a randomized cross-over design in which participants will consume kefir during one study period and continue their usual diet without kefir during another period.",[28],"Celiac Disease",[30,31,32],"celiac disease","kefir","gluten","NOT_YET_RECRUITING","2026-08-17",{"date":36,"type":37},"2026-08-20","ACTUAL",{"date":39,"type":22},"2026-09-30",{"date":41,"type":22},"2027-11-29",{"name":43,"class":44},"University Maribor","OTHER",1,{"id":47,"slug":48,"hasResults":12,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":4,"eligibilityCriteria":52,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":53,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":56,"briefSummary":58,"conditions":59,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":71},"100611342","phase-2-study-of-donq52-in-active-celiac-disease-100611342","NCT07239336","Study of DONQ52 in Active Celiac Disease","A Phase II, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate The Efficacy and Safety of DONQ52 in Active Celiac Disease Patients Who Have Duodenal Mucosal Damage and Persistent Symptoms Despite Attempting A Gluten-free Diet (DAISY STUDY)","Inclusion Criteria:\n\n* Body mass index (BMI) of 18 to 40 (kg\u002Fm2) at screening.\n* Willingness to ingest a gluten-free product and Simulated Inadvertent Gluten Exposure (SIGE) products as per the study protocol.\n* History of medically diagnosed, and adequately documented (i.e., included in the participant's medical records), CeD\n* Attempting a GFD for at least 12 months prior to the screening visit.\n\n  \\- The participants should be instructed not to alter dietary habits including a GFD during the study period.\n* Valid results from central testing of blood documenting a positive result for the HLA DQ2.5 genotype (HLA-DQA1\\*05 and HLA-DQB1\\*02) (homozygous or heterozygous).\n* Experienced at least 2 gluten-related symptom events (i.e., 2 different gluten-related symptoms which are diarrhea, abdominal pain, bloating, nausea, tiredness or 1 gluten-related symptom occurred twice) within a month before the screening.\n* Willingness to undergo 2 on-study upper gastrointestinal endoscopies with duodenal biopsies.\n* Presence of ongoing duodenal mucosal damage defined as Vh:Cd of 2.5 or less\n\nExclusion Criteria:\n\n* Participants with documented history (i.e., included in the participant's medical records) of medically diagnosed Refractory Celiac Disease (RCD) or suspected RCD by the investigator.\n* History of IgE-mediated reactions to wheat, barley, rye, or other ingredients in gluten-free and SIGE products used in this study (i.e., methylcellulose, and gelatin).\n* History of cancer, including hematological malignancy and solid tumors, within 5 years prior to the screening visit, or history of T cell lymphoma or B cell lymphoma ever.\n* History of hypersensitivity reactions including anaphylaxis to a biological medical product or any of the excipients.\n* Participants who carry the HLA-DQ8 (HLA-DQA1\\*03 and DQB1\\*0302) genotype (homozygous or heterozygous).\n* Any other chronic, active gastrointestinal disease (e.g., inflammatory bowel disease, microscopic colitis, eosinophilic esophagitis, peptic ulcer, gastroesophageal reflux disease, functional dyspepsia, or irritable bowel syndrome) that might in the investigator's opinion, interfere with the assessment of GI symptoms or small intestinal histology.\n* Helicobacter pylori tests that indicate current infection.\n* Positive either human immunodeficiency virus (HIV) antigen or antibody test at screening.\n* Positive hepatitis B surface antigen (HBsAg) test or total hepatitis B core (HBc) antibody test at screening.\n* Positive hepatitis C virus (HCV) antibody test at screening, except in participants who have negative results for HCV ribonucleic acid (RNA) test at screening.\n* Positive for QuantiFERON-TB Gold test at screening that indicates active tuberculosis (TB) at screening.","75 Years",{"count":55,"type":22},92,[57],"PHASE2","The main aim is to see how DONQ52 works to improve small intestinal damage and reduce celiac-related symptoms due to gluten exposure, in participants with celiac disease (CeD) attempting to maintain a gluten-free diet (GFD) in treated participants versus placebo controls.",[28],"RECRUITING","2026-08-13",{"date":63,"type":37},"2026-08-14",{"date":65,"type":37},"2025-12-16",{"date":67,"type":22},"2027-12-15",{"name":69,"class":70},"Chugai Pharmaceutical","INDUSTRY",74,{"id":73,"slug":74,"hasResults":12,"nctId":75,"briefTitle":76,"officialTitle":77,"acronym":4,"eligibilityCriteria":78,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":79,"enrollmentInfo":80,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":83,"conditions":84,"keywords":89,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":101},"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.","65 Years",{"count":81,"type":22},250,"OBSERVATIONAL","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.",[85,86,87,88,28],"Metabolic Dysfunction-Associated Steatotic Liver Disease","Non Celiac Wheat Sensitivity","Irritable Bowel Syndrome","Functional Dyspepsia",[90,91],"non-celiac wheat sensitivity","metabolic dysfunction-associated steatotic liver disease","2026-08-06",{"date":94,"type":37},"2026-08-11",{"date":96,"type":37},"2024-01-01",{"date":98,"type":22},"2030-12-31",{"name":100,"class":44},"University of Palermo",2,{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":23,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":45},"100650667","nutrition-and-physical-activity-education-in-children-with-celiac-disease-100650667","NCT07750795","Nutrition and Physical Activity Education in Children With Celiac Disease","Effect of Nutrition and Physical Activity Education on Anthropometric Measurements, Eating Behavior, and Quality of Life in Children With Celiac Disease","Inclusion Criteria Children aged 8 to 12 years (inclusive). Clinically diagnosed with celiac disease. Following a gluten-free diet for at least 6 months before enrollment. Able to understand study instructions and complete study assessments. Parent or legal guardian able to provide written informed consent. Child able to provide assent to participate. Exclusion Criteria Following a gluten-free diet for reasons other than celiac disease. Age younger than 8 years or older than 12 years. Refusal or inability of the parent\u002Flegal guardian to provide informed consent or of the child to provide assent.\n\nAny physical disability or medical condition that would limit participation in the physical activity program.","8 Years","12 Years",{"count":112,"type":22},54,[25],"Celiac disease is a chronic immune-mediated disorder that requires lifelong adherence to a gluten-free diet. Despite dietary treatment, children with celiac disease may experience nutritional inadequacies, unhealthy eating behaviors, reduced physical activity, and impaired quality of life. This randomized, single-blind, controlled trial aims to evaluate the effects of a structured nutrition education program combined with physical activity education on anthropometric measurements, eating behavior, physical activity, and health-related quality of life in children aged 8-12 years with celiac disease. Fifty-four participants will be randomly assigned to one of three groups: (1) nutrition and physical activity education, (2) physical activity education only, or (3) no education (control). Outcomes will be assessed at baseline and after a 6-week follow-up using validated questionnaires, anthropometric measurements, body composition analysis, and physical performance tests. The findings are expected to provide evidence for multidisciplinary educational interventions to improve the health and well-being of children with celiac disease.",[28,116,117],"Celiac Disease in Children","Celiac Disease in Adolescents","2026-08-02",{"date":92,"type":37},{"date":121,"type":37},"2026-05-01",{"date":123,"type":22},"2027-01-01",{"name":125,"class":44},"Bahçeşehir University",{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":23,"phases":134,"briefSummary":136,"conditions":137,"keywords":138,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":45},"100621972","phase-1-a-first-in-patient-study-to-evaluate-the-safety-and-tolerability-of-hb-2121-as-a-diagnostic-for-celiac-disease-100621972","NCT07377565","A First-in-Patient Study to Evaluate the Safety and Tolerability of HB-2121 as a Diagnostic for Celiac Disease","Inclusion Criteria:\n\n* Age 18 to 75 years\n* Undergoing esophagogastroduodenoscopy (EGD) for suspected celiac disease\n* Body Mass Index (BMI) between 18 and 45 kg\u002Fm2\n* Creatinine \\\u003C 1.5 x Upper Limit of the Normal (ULN)\n* Total bilirubin ≤ 1.5 mg\u002FdL x (ULN)\n* Aspartate aminotransferase (AST)\u002FSerum glutamic oxaloacetic transaminase (SGOT) \\& Alanine Aminotransferase (ALT)\u002FSerum glutamic pyruvic transaminase (SGPT) ≤ 1.5 x ULN\n* Overall good health, as determined by medical history and a physical exam\n* No use of an investigational drug within 12 weeks\n* Able and willing to follow study procedures and provide written informed consent\n* If of childbearing potential, participants must agree to use highly effective birth control during the study period. The same applies to male participants with partners of childbearing potential\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, planning to become pregnant, or intending to donate eggs during the study period\n* History of cancer or malignancy\n* History of chemotherapy and\u002For pelvic radiation\n* History of congenital long QT syndrome or prolonged QTcF interval\n* Prisoners, institutionalized individuals, or individuals who are unable to consent for themselves\n* Known HIV infection, or positive test for hepatitis B or C, or other clinically significant chronic liver disease\n* Current use of immunosuppressant medications\n* Known allergy or sensitivity to any ingredients in the study drug\n* History of eosinophilic enteritis, Crohn's disease, or ulcerative colitis",{"count":133,"type":22},20,[135],"PHASE1","The goal of this clinical trial is to learn about the safety of a single dose of HB-2121 in adults with suspected celiac disease. It will also look at how the drug affects the small intestine. The main questions it aims to answer are:\n\n* What side effects do participants have after receiving HB-2121?\n* How does the drug interact with the small intestine in people with suspected celiac disease?\n\nResearchers will follow participants for 30 days after receiving HB-2121 to understand how the drug behaves in the body and how safe it is.\n\nParticipants will:\n\n* Receive one oral dose of HB-2121 four hours before their standard-of-care esophagogastroduodenoscopy\n* Attend 4 in-person clinic visits for checkups, lab tests, and monitoring\n* Complete 2 remote visits that include safety lab assessments\n* Fill out a short daily questionnaire for 7 days about symptoms and health status",[28],[28,139,140,141],"HB-2121","Gluten Intolerance","Esophagogastroduodenoscopy","2026-07-24",{"date":144,"type":37},"2026-07-28",{"date":146,"type":37},"2026-04-29",{"date":148,"type":22},"2027-06-01",{"name":150,"class":44},"Nielsen Fernandez-Becker",{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":4,"eligibilityCriteria":156,"healthyVolunteers":157,"sex":18,"minAge":19,"maxAge":53,"enrollmentInfo":158,"targetDuration":4,"studyType":23,"phases":160,"briefSummary":161,"conditions":162,"keywords":163,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":170,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":177},"100491506","tissue-destruction-and-healing-in-celiac-disease-100491506","NCT05680012","Tissue Destruction and Healing in Celiac Disease","Inclusion Criteria:\n\nGluten challenge group:\n\n1. Age 18 to 75 years old\n2. Diagnosis of Celiac disease for at least 12 months by intestinal biopsy\n3. Follow a strict gluten-free diet for at least the 12 consecutive months\n\nGluten de-challenge group:\n\n1. Age 18 to 75 years old\n2. Showing typical celiac disease symptoms\n3. Not on a gluten-free diet\n\nControl group:\n\n1. Age 18 to 75 years old\n2. Females who are not pregnant\n\nExclusion Criteria:\n\nGluten challenge group:\n\n1. Diagnosis of any severe complication of celiac disease\n2. Diagnosis of other chronic, active GI disease\n3. Selective IgA deficiency\n4. Severe reaction to gluten exposure\n5. Any clinically significant diseases\n6. History of significant substance or alcohol abuse\n7. Pregnant or lactating\n8. Diagnosis of blood clotting disorders\n\nGluten de-challenge group:\n\n1. History of chronic inflammatory gastrointestinal disease\n2. Gastrointestinal illness within the 4-week period prior to screening\n3. History of lymphoproliferative disease\n4. Uncontrolled blood clotting disorders\n5. Any clinically significant diseases\n6. History of significant substance or alcohol abuse\n\nControl group:\n\n1. Taking antibiotics, proton pump inhibitors, aspirin, or non-steroidal anti-inflammatory drugs\n2. Known intestinal inflammation\n3. Prior gastrointestinal surgery\n4. Taking of antiplatelet agents or anticoagulants\n5. Family history of celiac disease",true,{"count":159,"type":22},220,[25],"The purpose of this clinical study is to learn more about celiac disease pathogenesis and clinical symptoms. In particular, this study will examine the interactions between biological factors such as, intestinal epithelial cells, microbiota, immune system, genetics, and gluten and their effect on celiac disease clinical symptoms, and severity of tissue destruction and its ability to heal in individuals with celiac disease. Information collected in the study will help researchers to generate better resources to advance celiac disease patient care.",[28],[164,165,166,167,168,169],"gluten-free diet","HLA-DQ2","HLA-DQ8","microbiome","metagenomics","intestinal epithelial cells",{"date":144,"type":37},{"date":172,"type":37},"2023-07-14",{"date":174,"type":22},"2027-07-01",{"name":176,"class":44},"University of Chicago",3,{"id":179,"slug":180,"hasResults":12,"nctId":181,"briefTitle":182,"officialTitle":182,"acronym":183,"eligibilityCriteria":184,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":185,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":187,"conditions":188,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":189,"lastUpdatePostDateStruct":190,"startDateStruct":192,"completionDateStruct":194,"leadSponsor":196,"locationsCount":4},"100645678","personalized-approach-to-celiac-disease-diagnosis-100645678","NCT07701655","Personalized Approach to Celiac Disease Diagnosis","PACkeD","For Aim 1:\n\nInclusion Criteria:\n\n* Patients ≥18 who underwent duodenal biopsy during upper endoscopy and had a TTG-IgA antibody test 3 months before or 1 month after biopsy\n\nExclusion Criteria:\n\n* Patients with a prior diagnosis of celiac disease undergoing biopsy and TTG-IgA antibody testing for follow-up care\n* Children and vulnerable populations (e.g. pregnant women or prisoners)\n* Patients with IgA deficiency\n* Patients already following a gluten-free diet\n\nFor Aim 2:\n\nInclusion Criteria:\n\n* Physicians (primary care or subspeciality) who test or evaluate patients for celiac disease\n* Patients already diagnosed with celiac disease or undergoing evaluation for celiac disease\n\nExclusion Criteria:\n\n\\- Children and vulnerable populations (e.g. pregnant women or prisoners)\n\nFor Aim 3:\n\nInclusion Criteria:\n\n* Patients ≥18 with a standard-of-care celiac disease evaluation (both TTG-IgA antibody and upper endoscopy with duodenal biopsy)\n* Willing to participate and able to provide informed consent\n\nExclusion Criteria:\n\n\\- Children and vulnerable populations (e.g. pregnant women or prisoners)",{"count":186,"type":22},15500,"The goal of this observational study is to learn about an adult's chance of having celiac disease based on blood testing and symptoms. The main question it aims to answer is:\n\nCan a blood test and symptom information separate patients into 3 groups of low, intermediate, and high risk for celiac disease?\n\nParticipants already being evaluated for celiac disease as part of regular medical care will answer online survey questions about symptoms and have laboratory data collected from charts.\n\nThe investigators hypothesize that a clinical prediction model integrating clinical data with TTG-IgA antibody levels can accurately identify patients with celiac disease offering a personalized approach. The investigators anticipate this prediction model would classify patients into 3 risk groups for celiac disease: 1) Low likelihood (no further testing required), 2) Intermediate likelihood (biopsy required for confirmation), and 3) High likelihood (biopsy can be avoided based on the model's accuracy) thereby reserving endoscopy and biopsies for cases of intermediate probability to improve diagnosis, reduce invasive testing, increase patient focus, and decrease costs.",[28],"2026-07-17",{"date":191,"type":37},"2026-07-20",{"date":193,"type":22},"2026-08",{"date":195,"type":22},"2031-04-30",{"name":197,"class":44},"The Cleveland Clinic",{"id":199,"slug":200,"hasResults":12,"nctId":201,"briefTitle":202,"officialTitle":203,"acronym":4,"eligibilityCriteria":204,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":205,"enrollmentInfo":206,"targetDuration":4,"studyType":23,"phases":208,"briefSummary":210,"conditions":211,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":212,"lastUpdatePostDateStruct":213,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100539934","early-phase-1-vtp-1000-in-adults-with-celiac-disease-100539934","NCT06310291","VTP-1000 in Adults With Celiac Disease","A Phase 1, First in Human, Randomized, Placebo-controlled Trial With a Controlled Gluten Challenge to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of VTP-1000 in Adults With Celiac Disease","Inclusion Criteria:\n\n* Diagnosis of celiac disease as confirmed by positive serology and intestinal histology\n* Presence of Human Leukocyte Antigen (HLA)-DQ2.5 genotype\n* Participants who are on a well controlled gluten restricted diet\n* Anti-tissue transglutaminase (tTG) IgA antibodies less than 2 times the upper limit of normal and anti-deamidated gliadin peptide IgG (anti-DGP)-IgA\u002FIgA antibodies less than 3 times the upper limit of normal\n* Non-pregnant or breast feeding females\n* No other clinical significant findings at screening\n\nExclusion Criteria:\n\n* Refractory celiac disease\n* Selective IgA deficiency\n* Positive for HLA-DQ8\n* Known wheat allergy or that is Type I hypersensitivity\n* Active inflammatory bowel disease or other condition with symptoms that will be similar to celiac disease","70 Years",{"count":207,"type":22},45,[209],"EARLY_PHASE1","GLU001 is a first-in-human clinical trial to assess the safety and tolerability of VTP-1000 for adults with celiac disease. This trial will assess VTP-1000 at various dose levels compared to placebo in a single ascending dose (SAD) and multiple ascending dose (MAD) format. Participants will be followed for a short period of time to assess the impact of VTP-1000 on their immune system (Adverse events, reactions in the blood, and physical exam differences). Participants enrolled in the MAD portion of the trial will undergo a gluten challenge to assess the impact exposure to gluten has on participants after administration of VTP-1000.",[28],"2026-06-17",{"date":214,"type":37},"2026-06-18",{"date":216,"type":37},"2024-08-01",{"date":218,"type":22},"2026-11",{"name":220,"class":70},"Barinthus Biotherapeutics",16,{"id":223,"slug":224,"hasResults":12,"nctId":225,"briefTitle":226,"officialTitle":226,"acronym":227,"eligibilityCriteria":228,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":53,"enrollmentInfo":229,"targetDuration":4,"studyType":23,"phases":231,"briefSummary":232,"conditions":233,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":234,"lastUpdatePostDateStruct":235,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":243},"100520680","gluten-technology-and-education-for-celiac-health-100520680","NCT06059716","Gluten Technology and Education for Celiac Health","GLUTECH","Inclusion Criteria:\n\n* Any gender; Age 18-75 years\n* Celiac disease diagnosis by serology and duodenal biopsy (corresponding to •Marsh 3 histology), adequate sampling and interpretable villus height to crypt depth ratio upon review by our study pathologist\n* Diagnosed with celiac disease within 4 months of initial study screening\n* Willingness to use gluten-detection technology\n* Not currently using a gluten detection technology that tests for gluten in urine or stool\n\nExclusion Criteria:\n\n* Currently pregnant or planning to become pregnant during the study\n* Not planning to follow a gluten-free diet\n* Concurrent participation in a clinical trial of an experimental pharmacologic agent (for any condition).",{"count":230,"type":22},200,[25],"The investigators propose to plan for a multi-center randomized controlled trial (M-RCT) to test the effectiveness of novel gluten detection technologies as an adjunct to telemedicine to manage celiac disease in newly diagnosed adults. If successful, the proposed intervention will improve mucosal recovery, promote a shift in current practice of celiac disease management toward long-term monitoring, and represent a significant step toward reducing the severe physical and psychological consequences of celiac disease.",[28],"2026-06-08",{"date":236,"type":37},"2026-06-10",{"date":238,"type":37},"2024-10-08",{"date":240,"type":22},"2028-08-31",{"name":242,"class":44},"Columbia University",4,{"id":245,"slug":246,"hasResults":12,"nctId":247,"briefTitle":248,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":23,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":261,"lastUpdatePostDateStruct":262,"startDateStruct":264,"completionDateStruct":266,"leadSponsor":268,"locationsCount":101},"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":251,"type":22},600,[25],"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).",[86,255,88,28],"IBS (Irritable Bowel Syndrome)",[257,258,259,30,260],"non celiac wheat sensitivity","irritable bowel syndrome","functional dyspepsia","Relatives","2026-05-07",{"date":263,"type":37},"2026-05-13",{"date":265,"type":37},"2026-04-01",{"date":267,"type":22},"2028-04-30",{"name":100,"class":44},{"id":270,"slug":271,"hasResults":12,"nctId":272,"briefTitle":273,"officialTitle":274,"acronym":275,"eligibilityCriteria":276,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":79,"enrollmentInfo":277,"targetDuration":4,"studyType":23,"phases":279,"briefSummary":280,"conditions":281,"keywords":282,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":285,"lastUpdatePostDateStruct":286,"startDateStruct":288,"completionDateStruct":290,"leadSponsor":292,"locationsCount":45},"100639792","effects-of-omega-3-fatty-acids-on-inflammation-and-gut-microbiota-in-celiac-disease-100639792","NCT07585669","Effects of Omega-3 Fatty Acids on Inflammation and Gut Microbiota in Celiac Disease","Modulation of Blood and Small Intestinal Inflammatory Processes and Fecal Microbiota in Celiac Disease Associated With the Intake of n-3 Polyunsaturated Fatty Acids","OMEGA-CD","Inclusion Criteria:\n\n* Adult patients aged 18 to 65 years, Newly diagnosed with celiac disease confirmed by serology and intestinal biopsy, Not yet started gluten-free diet (GFD), Willingness to adhere to a supervised gluten-free diet during the study, Able to provide informed consent\n\nExclusion Criteria:\n\n* Previous or current adherence to a gluten-free diet, Use of n-3 PUFA supplements or other dietary supplements influencing inflammation within the last 3 months, Presence of other autoimmune, inflammatory, or gastrointestinal diseases (e.g., Crohn's disease, ulcerative colitis), Pregnancy or breastfeeding, Severe chronic illnesses that may interfere with the study or outcomes (e.g., uncontrolled diabetes, cancer), Allergy or intolerance to fish oil or components of the supplement, Use of immunosuppressive or anti-inflammatory medication within the last 3 months",{"count":278,"type":22},40,[25],"The goal of this clinical trial is to learn if omega-3 fatty acid supplements (n-3 PUFAs) can help reduce inflammation and promote intestinal healing in adults newly diagnosed with celiac disease (CD).\n\nCeliac disease is a chronic autoimmune disorder where eating gluten-a protein found in wheat-triggers an immune response that damages the lining of the small intestine. This damage causes inflammation and symptoms such as stomach pain, diarrhea, and nutrient absorption problems. The only current treatment is a strict gluten-free diet (GFD), which can help most people recover, but some continue to have inflammation and symptoms.\n\nThis study will test whether supplementing with 2.4 grams of n-3 PUFAs daily for three months, alongside starting a gluten-free diet, reduces inflammation in the blood and intestine more effectively than the gluten-free diet alone.\n\nParticipants will:\n\nBe adults recently diagnosed with celiac disease who have not yet started a gluten-free diet\n\nBe randomly assigned to one of two groups:\n\nOne group will receive omega-3 supplements containing 2,400 mg of n-3 PUFAs daily (2,000 mg DHA and 400 mg EPA) The other group will receive a placebo (a pill with no active ingredients that looks like the supplement) Take the assigned supplement every day for 3 months while following a supervised gluten-free diet Visit the clinic regularly for checkups, blood tests, and monitoring of symptoms and diet adherence Provide blood and stool samples before and after the intervention to measure inflammation and changes in gut bacteria A subgroup of participants will undergo small intestinal biopsies to assess local inflammation and healing\n\nThe study aims to answer these main questions:\n\nDoes omega-3 supplementation change the fatty acid composition in blood cells? Does it reduce markers of inflammation in the blood and small intestine? Does it improve the diversity and health of gut bacteria in the intestine? Does it help the small intestine heal faster compared to diet alone?\n\nResearchers will measure inflammation by analyzing immune signaling pathways, oxidative stress markers, and antioxidant activity in blood cells. They will also study the composition of the gut microbiota and its metabolites. These detailed measurements will help understand how omega-3 fatty acids may influence the immune response and gut health in celiac disease.\n\nThis is a randomized, double-blind, placebo-controlled crossover study. This means participants and researchers will not know who receives the supplement or placebo during the study period, reducing bias and improving the reliability of the results.\n\nThis study is important because it could offer a simple, additional treatment to improve recovery in celiac disease beyond the gluten-free diet. If omega-3 supplements are shown to reduce inflammation and support healing, they could become a valuable part of managing this chronic condition.\n\nParticipation is voluntary, and participants can leave the study at any time without affecting their medical care. All participants will be closely monitored to ensure safety throughout the study.",[28],[28,283,284],"Intestinal Inflammation","Omega-3 Fatty Acids","2026-05-06",{"date":287,"type":37},"2026-05-14",{"date":289,"type":37},"2025-10-01",{"date":291,"type":22},"2026-12-30",{"name":293,"class":44},"University of Chile",{"id":295,"slug":296,"hasResults":12,"nctId":297,"briefTitle":298,"officialTitle":299,"acronym":300,"eligibilityCriteria":301,"healthyVolunteers":157,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":302,"targetDuration":304,"studyType":82,"phases":4,"briefSummary":305,"conditions":306,"keywords":309,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":323,"completionDateStruct":325,"leadSponsor":327,"locationsCount":177},"100635718","histomolecular-profiling-in-small-bowel-diseases-100635718","NCT07556328","Histomolecular Profiling in Small-Bowel Diseases","Histological and Molecular Profiling in the Diagnostics and Treatment of Small-Bowel Diseases - A Prospective Cohort Study (The DeepBowel Study)","Deep Bowel","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Clinically indicated upper gastrointestinal endoscopy (gastroscopy)\n* Written informed consent obtained prior to procedure\n* For Group 1 (Healthy Controls): Negative celiac disease antibodies (anti-transglutaminase and\u002For anti-endomysium); no suspected celiac\n* For Group 2 (Celiac Diagnostics): Referred for primary celiac disease diagnostics requiring duodenal biopsy\n* For Group 3 (Refractory Injury): Confirmed small-bowel mucosal injury not responsive to a gluten-free diet\n\nExclusion Criteria:\n\n* For Group 1 (Healthy Controls): Other small-bowel diseases causing mucosal injury, including Crohn's disease and small-bowel ulcers\n* Inability to provide written informed consent\n* Refusal to participate",{"count":303,"type":22},300,"12 Months","This prospective cohort study aims to establish reliable histological reference values for normal small-bowel mucosa, improve histological diagnostic quality in celiac disease, and develop an advanced molecular profile for disease diagnosis and treatment response evaluation. The study will collect duodenal biopsies from three groups: healthy controls undergoing clinically indicated gastroscopy, patients referred for primary celiac disease diagnostics, and patients with small-bowel mucosal injury unresponsive to a gluten-free diet. Patients will undergo routine clinical assessment via standard pathology review of diagnostic biopsies. Biopsies will be analyzed using digital morphometry, AI-based image analysis, RNA sequencing (transcriptomics), and intestinal organoid cultures.",[28,307,308],"Small Bowel Disease","Refractory Celiac Disease",[30,310,311,312,313,314,315,316,317,318,319,320],"duodenal biopsy","histology","digital morphometry","artificial intelligence","RNA sequencing","transcriptomics","organoids","small bowel","villous atrophy","molecular profiling","machine learning","2026-04-24",{"date":146,"type":37},{"date":324,"type":37},"2025-11-01",{"date":326,"type":22},"2035-12-31",{"name":328,"class":44},"Tampere University Hospital",{"id":330,"slug":331,"hasResults":12,"nctId":332,"briefTitle":333,"officialTitle":334,"acronym":335,"eligibilityCriteria":336,"healthyVolunteers":12,"sex":18,"minAge":109,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":23,"phases":340,"briefSummary":341,"conditions":342,"keywords":345,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":353,"startDateStruct":355,"completionDateStruct":357,"leadSponsor":358,"locationsCount":45},"100620825","single-cell-immune-response-to-controlled-gluten-ingestion-in-pediatric-celiac-disease-100620825","NCT07362654","Single-cell Immune Response to Controlled Gluten Ingestion in Pediatric Celiac Disease","Single-cell Study of the Systemic Immune Response to Controlled Gluten Intake in Pediatric Celiac Disease","CELLiomicS","Inclusion Criteria:\n\n* Age 8 to 14 years at study entry.\n* Diagnosis of celiac disease according to ESPGHAN 2020 criteria.\n* At least 18 months on a strict gluten-free diet (GFD).\n* Adequate adherence to the GFD, demonstrated by negative fecal gluten immunogenic peptides (GIP) prior to inclusion.\n* Asymptomatic from a gastrointestinal perspective in the preceding weeks.\n* Ability to swallow the gluten\u002Fplacebo preparation.\n* Written informed consent from parents\u002Flegal guardians and assent from the child.\n\nExclusion Criteria:\n\n* Obesity defined as BMI ≥ 95th percentile according to WHO criteria.\n* Diagnosed inflammatory bowel disease or diabetes mellitus.\n* Acute infectious illness at the time of inclusion.\n* Chronic hepatic, pulmonary, renal, or rheumatologic disease.\n* History of severe acute reactions to accidental gluten ingestion.\n* Use of oral corticosteroids or immunosuppressive therapy in the previous 3 months.\n* Any condition that, in the opinion of the investigators, may contraindicate participation or compromise study integrity.","14 Years",{"count":339,"type":22},51,[25],"This study investigates how the immune system of children with celiac disease responds to controlled, small amounts of gluten. Children on a strict gluten-free diet are randomly assigned to receive either placebo, 50 mg of gluten, or 5 g of gluten once daily for three days, simulating real-life accidental exposure or dietary transgression. Blood samples are collected on Day 1 (before gluten intake) and Day 8 (five days after the last dose). Stool and urine samples are also collected for complementary analyses.\n\nUsing single-cell ribonucleic acid (RNA) sequencing, T-cell receptor sequencing, microRNA profiling, and exploratory metabolomics, the study aims to characterize changes in immune cell populations and gene expression after gluten exposure. The objective is to determine whether even very small amounts of gluten induce measurable systemic immune responses and whether these responses differ according to the dose administered. Understanding these mechanisms may support the development of new biomarkers and improve clinical management of pediatric celiac disease.",[28,343,344],"Gluten Sensitivity","Autoimmune Diseases",[28,346,347,348,349,350,351],"Gluten Exposure","Single-Cell RNA Sequencing","Gluten-Free Diet","Immune Response","Pediatrics","Omics","2026-04-22",{"date":354,"type":37},"2026-04-27",{"date":356,"type":37},"2025-07-07",{"date":218,"type":22},{"name":359,"class":44},"Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud",{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":368,"targetDuration":4,"studyType":23,"phases":369,"briefSummary":370,"conditions":371,"keywords":374,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":352,"lastUpdatePostDateStruct":383,"startDateStruct":385,"completionDateStruct":387,"leadSponsor":389,"locationsCount":45},"100598256","hydroxyapatite-based-home-treatment-for-dentin-sensitivity-in-celiac-patients-100598256","NCT07069127","Hydroxyapatite-Based Home Treatment for Dentin Sensitivity in Celiac Patients","Reduction of Dentin Hypersensitivity and Enamel Demineralization in Patients With Celiac Disease: A Randomized Controlled Trial","CELIADENT","Inclusion Criteria:\n\n* Adults (≥18 years of age) with a confirmed diagnosis of celiac disease.\n* Presence of enamel defects (hypomineralization or demineralization).\n* Presence of active carious lesions.\n* Self-reported dentin hypersensitivity.\n* Willingness to comply with the study protocol and follow-up schedule.\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* Age below 18 years.\n* Absence of confirmed celiac disease.\n* Poor compliance or low motivation to participate in a 6-month study.\n* Ongoing treatment with products affecting enamel mineralization.\n* Pregnancy or breastfeeding.\n* Participation in another clinical trial within the previous 30 days.",{"count":278,"type":22},[25],"This single-center, randomized controlled clinical trial aims to evaluate the effectiveness of a home-based treatment using hydroxyapatite-based oral care products in adult patients with celiac disease who exhibit enamel demineralization and dentin hypersensitivity. Forty patients will be enrolled and randomly allocated into two parallel groups. The control group will perform home oral hygiene using only a hydroxyapatite-based toothpaste (Biorepair® Total Protection) twice daily. The trial group will follow the same regimen with the toothpaste, but will also apply a hydroxyapatite mousse (Biorepair® Plus Intensive Enamel Repair) once every evening before bedtime throughout the study period.\n\nThe primary objective is to assess the reduction in dentin hypersensitivity using the Schiff Air Index. Secondary outcomes include changes in plaque accumulation (Plaque Index), gingival bleeding (Bleeding on Probing), pain perception (Visual Analogue Scale), and caries experience (DMFT and DMFS indices). Enamel demineralization will be analyzed through near-infrared transillumination (DIAGNOcam), laser fluorescence (DIAGNOdent), and digital image analysis (ImageJ software).\n\nAll clinical parameters will be evaluated at baseline and after 1 week, 1 month, 3 months, and 6 months. The study seeks to determine whether the addition of a remineralizing mousse to daily oral care provides superior benefits in reducing sensitivity and improving enamel integrity in patients with celiac disease.",[28,372,373],"Dentin Hypersensitivity","Tooth Demineralization",[28,372,375,376,377,378,379,380,381,382],"Enamel Demineralization","Hydroxyapatite","Remineralizing Agents","Biorepair","Toothpaste","Oral Mousse","Dental Sensitivity","Randomized Controlled Trial",{"date":384,"type":37},"2026-04-23",{"date":386,"type":37},"2025-07-30",{"date":388,"type":22},"2026-09-10",{"name":390,"class":44},"University of Pavia",{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":399,"enrollmentInfo":400,"targetDuration":4,"studyType":23,"phases":401,"briefSummary":402,"conditions":403,"keywords":404,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":413,"startDateStruct":415,"completionDateStruct":417,"leadSponsor":419,"locationsCount":101},"100596001","gluten-challenge-in-celiac-disease---which-formulation-of-gluten-gives-the-best-response-100596001","NCT07039773","Gluten Challenge in Celiac Disease - Which Formulation of Gluten Gives the Best Response?","Assessing Immune Responses to Gluten: A Comparative Study of Liquid Versus Solid Gluten Administration","SHAKE","Inclusion Criteria:\n\n* BMI 18-33 kg\u002Fm2\n* Willingness to comply with the study procedure and having signed informed, written consent\n* Previous diagnosis of coeliac disease according to established guidelines based on positive serology (Endomysium test, IgA-TG2 and\u002For IgG-DGP) (diagnosed in childhood) and a duodenal biopsy showing villous atrophy graded as Marsh 3 according to guidelines from European Society for Study of Coeliac Disease .\n* Strict adherence to a gluten-free diet at least the 12 last months.\n\nExclusion Criteria:\n\n* Positive serology (IgA-TG2 below upper level of normal) at screening visit\n* Pregnancy or breast feeding. Fertile women must use effective contraception.\n* Other inflammatory disease like uncontrolled hypothyreosis, type 1 diabetes, cardiovascular diseases, thyroid and renal disorders, inflammatory bowel diseases or any other disease that in the opinion of the responsible clinician makes the patient unsuitable for the study\n* Using of immunosuppressive\u002Fsteroid medications\n* Wheat allergy\n* Severe acute infection","80 Years",{"count":21,"type":22},[25],"The goal of this clinical trial is to evaluate the immune response to gluten in patients with celiac disease (CeD) by comparing different forms of gluten administration. The participant population includes adults diagnosed with CeD, who are adhering to a gluten-free diet (GFD). The main questions it aims to answer are:\n\n* Does liquid gluten administration elicit a higher IL-2 cytokine response compared to solid gluten administration?\n* What is the relationship between serum IL-2 levels and gluten peptide serum concentrations following gluten challenges?\n\nResearchers will compare the responses of two groups: participants receiving liquid gluten (shake) to those receiving solid gluten (cookie) to determine if there is a significant difference in the IL-2 response rates between the two forms.\n\nParticipants will be asked to:\n\n* Undergo two gluten challenges (liquid and solid) in a randomized order with at least 4 weeks apart.\n* Provide blood samples before and after each challenge to measure serum IL-2 levels and gluten peptide concentrations over a period of 6 hours.\n* Report any symptoms experienced following each gluten challenge.",[28],[405,406,407,408,409,410,411],"Gluten challenge","Interleukin-2","Shake","Cookie","T cells","Whole blood cytokine release assay","GI Symptoms","2026-04-14",{"date":414,"type":37},"2026-04-17",{"date":416,"type":37},"2025-08-01",{"date":418,"type":22},"2026-12",{"name":420,"class":44},"Oslo University Hospital",{"id":422,"slug":423,"hasResults":12,"nctId":424,"briefTitle":425,"officialTitle":426,"acronym":427,"eligibilityCriteria":428,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":429,"enrollmentInfo":430,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":432,"conditions":433,"keywords":434,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":412,"lastUpdatePostDateStruct":440,"startDateStruct":441,"completionDateStruct":443,"leadSponsor":445,"locationsCount":101},"100213878","celiac-disease-genomic-environmental-microbiome-and-metabolomic-study-100213878","NCT02061306","Celiac Disease Genomic Environmental Microbiome and Metabolomic Study","Celiac Disease Genomic Environmental Microbiome and Metabolomic (CDGEMM) Study","CDGEMM","Inclusion Criteria:\n\n* Newborns and infants less than 6 months of age who have not been introduced to solid foods (exclusive breast milk or formula diet)\n* First-degree relatives of patients affected with biopsy-proven CD\n\nExclusion Criteria:\n\n* Infants older than 6 months of age\n* Inability or unwillingness of legal guardian\u002Frepresentative to give written informed consent","6 Months",{"count":431,"type":22},500,"Celiac disease (CD) is a complex disease caused by eating gluten, a protein contained in wheat, rye, and barley. It is well known that many factors contribute to the development of CD, including the genes that you have and the foods that you eat. In the CDGEMM study, we will consider as many of these factors as possible and study how they each contribute to disease development. If the investigators find that any one factor, or combination of factors, increases the risk of developing CD, we will be able to apply this information and help prevent or detect disease in high-risk children in the future.",[28],[435,436,167,32,437,438,439],"Celiac disease","coeliac disease","infants","pregnancy","genetic",{"date":414,"type":37},{"date":442,"type":4},"2014-03",{"date":444,"type":22},"2027-12",{"name":446,"class":44},"Massachusetts General Hospital",{"id":448,"slug":449,"hasResults":12,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":453,"eligibilityCriteria":454,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":399,"enrollmentInfo":455,"targetDuration":4,"studyType":23,"phases":457,"briefSummary":458,"conditions":459,"keywords":460,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":462,"startDateStruct":464,"completionDateStruct":466,"leadSponsor":468,"locationsCount":45},"100615879","phase-2-evaluating-the-efficacy-and-tolerability-of-zed1227-in-subjects-with-non-responsive-celiac-disease-100615879","NCT07298343","Evaluating the Efficacy and Tolerability of ZED1227 in Subjects With Non-responsive Celiac Disease","A Phase II, Double-blind, Randomised, Placebo-controlled Trial to Evaluate the Efficacy and Tolerability of ZED1227 in Celiac Disease Subjects Experiencing Symptoms Despite Gluten-free Diet","CEC-013\u002FCEL","Inclusion Criteria:\n\n* Signed informed consent\n* Men or women between 18 and 80 years of age, inclusively\n* Documented initial biopsy-proven diagnosis of celiac disease or, in case of missing histological documentation, TG2-IgA \\> 10 x upper limit of normal (ULN) at diagnosis at least 12 months prior to V0\n* Adherence to a gluten-free diet (GFD) for at least 12 months prior to V0\n* Human leukocyte antigen DQ (HLA-DQ) typing compatible with celiac disease\n\nExclusion Criteria:\n\n* Presence of hypo- or hyperthyroidism. A patient with a well-controlled thyroid disorder during the previous 3 months can be included\n* Patients diagnosed to have confirmed refractory celiac disease type I (RCDI) or II (RCDII), with the exception that patients with a diagnosis of RCDI can be considered for inclusion if they do not have clear signs of T cell monoclonality or atypical T cells (e.g., as revealed by CD3\u002FCD8 immunohistochemistry) and if they do not present with very severe symptoms and\u002For parameters of significant malabsorption and if they have not received prior treatment with immunosuppressants such as budesonide or azathioprine,\n* Severe complications of celiac disease\n* Concomitant diseases of the intestinal tract in addition to celiac disease, such as Crohn's disease, ulcerative colitis, other forms of inflammatory bowel disease, severe irritable bowel syndrome, microscopic colitis, small intestinal bacterial overgrowth (SIBO), exocrine pancreatic insufficiency; any other active diseases of the intestinal tract (e.g., active, untreated peptic ulcer, esophagitis, gastroesophageal reflux disease) that might, in the investigator's opinion, interfere with assessment of symptoms of abdominal pain, diarrhoea, or other components of celiac disease\n* History or presence of dermatitis herpetiformis",{"count":456,"type":22},356,[57],"A study to discover if ZED1227 can improve continued celiac disease symptoms despite a gluten-free diet",[28],[28,461],"non-responsive Celiac Disease",{"date":463,"type":37},"2026-04-02",{"date":465,"type":37},"2024-06-10",{"date":467,"type":22},"2027-08",{"name":469,"class":70},"Dr. Falk Pharma GmbH",{"id":471,"slug":472,"hasResults":12,"nctId":473,"briefTitle":474,"officialTitle":475,"acronym":4,"eligibilityCriteria":476,"healthyVolunteers":157,"sex":18,"minAge":477,"maxAge":4,"enrollmentInfo":478,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":480,"conditions":481,"keywords":485,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":490,"lastUpdatePostDateStruct":491,"startDateStruct":493,"completionDateStruct":495,"leadSponsor":497,"locationsCount":4},"100627819","small-bowel-ultrasound-and-antibody-levels-in-celiac-disease-activity-100627819","NCT07453589","Small Bowel Ultrasound and Antibody Levels in Celiac Disease Activity","Ultrasound Small Bowel Patterns and Tissue Transglutaminase Antibody Levels in Celiac Disease Activity","Inclusion Criteria:\n\n* Patients aged ≥2 years with suspected celiac disease based on clinical symptoms (chronic diarrhea, abdominal distention, weight loss, failure to thrive).\n* Newly diagnosed celiac disease patients with positive tTG antibodies and\u002For duodenal biopsy confirmation.\n* Previously diagnosed celiac disease patients on gluten-free diet requiring follow-up assessment.\n* Patients with first-degree relatives with celiac disease undergoing screening.\n* Patients who provide informed consent (or parental consent for minors).\n\nExclusion Criteria:\n\n* Previous small bowel surgery or resection.\n* Inflammatory bowel disease (Crohn's disease, ulcerative colitis).\n* Small bowel obstruction from other causes.\n* IgA deficiency (requires alternative antibody testing).\n* Patients on immunosuppressive therapy.\n* Pregnancy.\n* Poor quality ultrasound images due to excessive bowel gas or obesity.\n* Refusal to participate in the study.","2 Years",{"count":479,"type":22},140,"This observational study aims to evaluate the relationship between small bowel ultrasound findings and tissue transglutaminase (tTG) antibody blood levels in assessing celiac disease activity. The traditional gold standard for diagnosing and monitoring celiac disease involves an invasive duodenal biopsy. Researchers want to determine if combining a painless, non-invasive small bowel ultrasound with tTG antibody blood tests can accurately predict disease severity and monitor a patient's response to a gluten-free diet.\n\nThe study will enroll 140 participants aged 2 years and older, including newly diagnosed patients, patients currently on a gluten-free diet, and a control group. All participants will undergo a clinical assessment, blood tests for tTG antibodies, and a high-resolution small bowel ultrasound. Newly diagnosed patients will also undergo an upper gastrointestinal endoscopy and biopsy to confirm their diagnosis. Researchers will score the ultrasound severity based on factors like bowel wall thickness and compare it to the antibody levels. A cohort of patients will be monitored over time with serial assessments at baseline, 6 months, and 12 months.",[28,482,483,484],"Ultrasound","Tissue Transglutaminase Antibody","Small Bowel Ultrasonography",[435,486,487,488,489],"Small bowel ultrasonography","Tissue transglutaminase","Gluten-free diet","Duodenal biopsy","2026-03-02",{"date":492,"type":37},"2026-03-06",{"date":494,"type":22},"2026-04",{"date":496,"type":22},"2027-05",{"name":498,"class":44},"Assiut University",{"id":500,"slug":501,"hasResults":12,"nctId":502,"briefTitle":503,"officialTitle":503,"acronym":504,"eligibilityCriteria":505,"healthyVolunteers":12,"sex":18,"minAge":4,"maxAge":4,"enrollmentInfo":506,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":508,"conditions":509,"keywords":514,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":518,"lastUpdatePostDateStruct":519,"startDateStruct":520,"completionDateStruct":522,"leadSponsor":524,"locationsCount":45},"100527786","development-of-new-diagnostic-tools-in-capsule-endoscopy-100527786","NCT06152289","Development of New Diagnostic Tools in Capsule Endoscopy","NOCE","Inclusion Criteria:\n\n\\- Any patient in whom a capsule endoscopy examination is performed as part of routine care.\n\nExclusion Criteria:\n\n\\- Opposition to the use of images and videos from daily, routine care for research purposes.",{"count":507,"type":22},10000,"Patients participating to this study will provide images and videos of capsule endoscopy to train, tune and evaluate technological bricks of artificial intelligence solutions, in order to improve diagnostic performances of the procedure, while reducing reading time by physicians.",[510,511,28,512,513],"Bowel Disease","Crohn Disease","Chronic Diarrhea","Tumor",[515,516,517],"Small bowel","Capsule endoscopy","Artificial intelligence","2026-02-27",{"date":490,"type":37},{"date":521,"type":37},"2023-02-10",{"date":523,"type":22},"2028-02",{"name":525,"class":44},"Assistance Publique - Hôpitaux de Paris",{"id":527,"slug":528,"hasResults":12,"nctId":529,"briefTitle":530,"officialTitle":531,"acronym":532,"eligibilityCriteria":533,"healthyVolunteers":157,"sex":18,"minAge":534,"maxAge":535,"enrollmentInfo":536,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":538,"conditions":539,"keywords":541,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":553,"lastUpdatePostDateStruct":554,"startDateStruct":555,"completionDateStruct":557,"leadSponsor":559,"locationsCount":243},"100399188","general-population-level-estimation-for-type-1-diabetes-risk-in-children-during-routine-care-delivery-100399188","NCT04477928","General Population Level Estimation for Type 1 Diabetes Risk in Children During Routine Care Delivery","Sanford Population Level Estimation of Type 1 Diabetes Risk GEnes in Children","PLEDGE","Inclusion Criteria:\n\n* Newborn Entry: Viable, term infants, defined as 36 weeks gestation by either dates or ultrasound who are born to pregnant women, 18 years or older, who are willing and able to provide informed consent (IC) prior to the onset of active labor. Who are born at a Sanford Health Hospital and plan to have routine well-child care at a Sanford Clinic\n* Pediatric Entry: Children less than 6 years of age who receive their routine care at a Sanford facility and whose parents are able to provide IC.\n* Adolescent Entry: Children, ages 9-16 years old, who receive their routine care at a Sanford facility and whose parents are able to provide IC.\n* Siblings of children known to have T1D-relevant antibodies; ages 6 to 17 years old who receive care at a Sanford clinic\n* Have an active MyChart account (with proxy access).\n\nExclusion Criteria:\n\n* Subject is in the opinion of the investigator, unable to comply with the requirements of the study protocol.\n* Children known to have T1D","0 Minutes","17 Years",{"count":537,"type":22},33000,"In partnership with Helmsley Charitable Trust, the Sanford PLEDGE Study is a large-scale, observational, feasibility study of general population screening for T1D and celiac autoantibodies. Screening is incorporated into routine health care visits within an integrated health system.",[540,28],"Type 1 Diabetes",[542,540,28,543,544,545,546,547,548,549,550,551,552],"Population screening","Autoantibodies","Prevention","Diabetic Ketoacidosis (DKA)","Genetic Risk Score","Differential Gene Expression","Economic Modeling","Quality of Life","Feasibility","Pragmatic","T1D","2026-02-26",{"date":490,"type":37},{"date":556,"type":37},"2020-07-17",{"date":558,"type":22},"2031-03",{"name":560,"class":44},"Sanford Health",{"id":562,"slug":563,"hasResults":12,"nctId":564,"briefTitle":565,"officialTitle":566,"acronym":4,"eligibilityCriteria":567,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":568,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":570,"conditions":571,"keywords":574,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":580,"lastUpdatePostDateStruct":581,"startDateStruct":583,"completionDateStruct":585,"leadSponsor":587,"locationsCount":45},"100622712","ai-system-for-detection-and-characterization-of-chronic-enteropathies-100622712","NCT07387185","AI System for Detection and Characterization of Chronic Enteropathies","Development and Validation of an Artificial Intelligence System for Detection and Characterization of Small Bowel Mucosal Atrophy in Celiac Disease and Non-Celiac Enteropathies: A Multicenter Observational Study","Inclusion Criteria:\n\n* Adult patients (age ≥18 years).\n* Patients undergoing endoscopic investigation of the small bowel (endoscopy or capsule endoscopy)\n\nExclusion Criteria:\n\n* Inability to provide informed consent.",{"count":569,"type":22},380,"Coeliac disease (CD) is an immune-mediated enteropathy leading to small intestinal mucosal atrophy. Diagnosis relies on serology and duodenal biopsies, but it can be complicated by patchy lesions and differential diagnosis with Non-Celiac Enteropathies (NCEs). This multicenter observational study aims to develop and validate an Artificial Intelligence (AI) system to detect and characterize small bowel mucosal atrophy and other pathological findings using endoscopic imaging. The study involves a retrospective phase for training the AI model and a prospective phase to validate its diagnostic accuracy compared to standard human assessment.",[28,572,573],"Small Bowel Mucosal Atrophy or Lesions","Non-celiac Enteropathies",[575,576,577,578,579],"Artificial Intelligence","Endoscopy","Deep Learning","Computer-Aided Diagnosis","Small Bowel","2026-01-28",{"date":582,"type":37},"2026-02-04",{"date":584,"type":37},"2025-02-20",{"date":586,"type":22},"2028-03-01",{"name":588,"class":44},"Istituti Clinici Scientifici Maugeri SpA",{"id":590,"slug":591,"hasResults":12,"nctId":592,"briefTitle":593,"officialTitle":594,"acronym":4,"eligibilityCriteria":595,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":596,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":597,"conditions":598,"keywords":603,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":610,"lastUpdatePostDateStruct":611,"startDateStruct":613,"completionDateStruct":615,"leadSponsor":617,"locationsCount":45},"100621094","long-term-health-outcomes-of-screen-detected-and-potential-celiac-disease-patients-100621094","NCT07366151","Long-term Health Outcomes of Screen Detected and Potential Celiac Disease Patients","The Impact of Active Screening on the Long-term Health of Celiac Disease Patients and the Natural Course of Potential Untreated or Treated Celiac Disease","Inclusion Criteria:\n\n* Finnish citizenship and current residence in Finland\n\nExclusion Criteria:\n\n* Age \\\u003C18 years",{"count":81,"type":22},"The primary aim of this project is to investigate how active screening and the timing of diagnosis affect the long-term health outcomes of patients with celiac disease. Additionally, the study seeks to clarify the natural course of so-called potential celiac disease. A key focus is also placed on assessing adherence to a gluten-free diet among screen-detected and, if initiated, potential celiac disease patients, their satisfaction with the diagnosis, and the diet's impact on general health and quality of life.",[599,600,601,602,28],"Malabsorption Syndromes","Intestinal Diseases","Gastrointestinal Disease","Digestive System Diseases",[435,604,488,605,606,607,608,609],"Potential celiac disease","Screen detected","Long-term health","Quality of life","Symptoms","Asymptomatic","2026-01-23",{"date":612,"type":37},"2026-01-26",{"date":614,"type":22},"2026-03-01",{"date":616,"type":22},"2034-12",{"name":328,"class":44},{"id":619,"slug":620,"hasResults":12,"nctId":621,"briefTitle":622,"officialTitle":623,"acronym":4,"eligibilityCriteria":624,"healthyVolunteers":157,"sex":18,"minAge":477,"maxAge":4,"enrollmentInfo":625,"targetDuration":626,"studyType":82,"phases":4,"briefSummary":627,"conditions":628,"keywords":670,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":692,"lastUpdatePostDateStruct":693,"startDateStruct":695,"completionDateStruct":697,"leadSponsor":698,"locationsCount":45},"100424417","unhide-project-a-digital-health-platform-to-collect-lifestyle-data-for-brain-inflammation-research-100424417","NCT04806620","Unhide® Project: A Digital Health Platform to Collect Lifestyle Data for Brain Inflammation Research","Unhide® Project Also Known as The Unhide® Solve Together Unified Platform","Participants may be either self-diagnosed, or diagnosed by a physician with the following conditions:\n\n* Infection-associated chronic conditions such as Long COVID, chronic Lyme, myalgic encephalomyelitis (ME\u002FCFS), and post-acute neuropsychiatric syndrome (PANS\u002FPANDAS).\n* Neuroimmune, developmental, autonomic, and neurological conditions like migraines, dysautonomia, POTS, multiple sclerosis, and autism spectrum disorder.\n* Autoimmune diseases such as Lupus, Sjogren's Disease, rheumatoid arthritis, myasthenia gravis, ankylosing spondylitis, and related autoimmune conditions.\n\nInflammatory gastrointestinal conditions such as Crohn's Disease, Celiac Disease, and ulcerative colitis.\n\n* Behavioral and mood disorders such as anxiety, depression, bipolar disorder, PTSD, eating disorders, OCD, and other related conditions.\n* \"Healthy\" people (without brain inflammation), including unaffected individuals, unaffected individuals in the same household, and unaffected individuals who are married to relatives and family members.\n* Have consistent internet access and a cell phone, tablet, or PC since this is an online or app-based platform that requires entering data and completing surveys.\n* Currently live in the United States\n* Be able to participate in English (stay tuned for updates about the Spanish language version)\n* Be willing to share symptom and health data through the platform",{"count":507,"type":22},"10 Years","The unhide® Project is a non-interventional, longitudinal research study designed to establish a secure data repository of demographic, health, and lifestyle information from individuals with brain inflammation and related neuroinflammatory conditions. Participants in the United States aged 2 years and older will provide self-reported health data, biometrics, and symptom diaries through the MyDataHelps™ app (branded as unhide® for this study). The goal is to create comprehensive longitudinal profiles to facilitate research into disease subtypes, causes, diagnostics, and potential treatments, as well as to identify potential participants for future optional studies. \"Healthy\" individuals without brain inflammation are also eligible to participate.\n\nThe digital health research platform used in this study was originally developed and designed by Solve M.E and was called SolveTogether. The Brain Inflammation Collaborative (BIC) expanded upon Solve M.E.'s work to include related diagnoses, pediatric participants, enhance symptom tracking, and more. BIC and Solve M.E. combined Solve Together and unhide®, to create The unhide® Solve Together Unified Platform in 2025.",[629,630,631,632,633,634,635,28,116,636,637,638,639,640,641,642,643,644,645,646,647,648,649,650,651,652,653,654,655,656,657,658,659,660,661,662,663,664,665,344,666,667,668,669],"Post-Acute COVID-19 Syndrome","ME\u002FCFS","Rheumatic Arthritis","Juvenile Rheumatoid Arthritis (JRA)","Psoriatic Arthritis (PsA)","Ankylosing Spondylitis (AS)","Autoimmune Encephalitis","Chronic Lyme Disease","Post-treatment Lyme Disease Syndrome","Crohn's Disease","Dysautonomia","Anorexia Nervosa","Bulimia Nervosa","ARFID","Avoidant \u002F Restrictive Food Intake Disorder","Ehlers Danlos Syndrome","Endometriosis","Fibromyalgia (FM)","Long COVID","Lupus","Migraines","Mast Cell Activation Syndrome","Multiple Sclerosis","Myalgic Encephalomyelitis (ME)","Myasthenia Gravis, Generalized","Myasthenia Gravis in Children","Narcolepsy","Obsessive Compulsive Disorder (OCD)","PANDAS","Pediatric Acute-onset Neuropsychiatric Syndrome (PANS)","POTS - Postural Orthostatic Tachycardia Syndrome","General Anxiety Disorder, Social Anxiety Disorder","PTSD - Post Traumatic Stress Disorder","Psoriasis","Traumatic Brain Injury","Tourette's Syndrome","Inflammatory Bowel Disease (IBD)","Neurological Diseases or Conditions","Psychiatric Disorder","Sjogren's Syndrome","Ulcerative Colitis and Crohn's Disease",[647,671,672,673,674,675,676,677,678,679,630,680,681,682,683,435,649,684,685,686,687,688,689,690,691],"Myalgic Encephalomyelitis","Chronic Fatigue Syndrome","Longitudinal Natural History Study","Observational","Neuroinflammatory Disease","Brain inflammation","Neuroinflammatory disorders","PANS\u002FPANDAS","Autoimmune encephalitis","Dysautonomia \u002F POTS","Multiple sclerosis","Autoimmune disease","Inflammatory bowel disease (Crohn's, ulcerative colitis)","Mood disorders (anxiety, depression, bipolar, PTSD, OCD)","Mobile health app","Patient registry","Wearable devices","Fatigue","Post-exertional malaise","Brain Fog","Mental health","2026-01-20",{"date":694,"type":37},"2026-01-22",{"date":696,"type":37},"2023-07-05",{"date":98,"type":22},{"name":699,"class":44},"Brain Inflammation Collaborative",{"id":701,"slug":702,"hasResults":12,"nctId":703,"briefTitle":704,"officialTitle":704,"acronym":4,"eligibilityCriteria":705,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":4,"enrollmentInfo":706,"targetDuration":4,"studyType":82,"phases":4,"briefSummary":707,"conditions":708,"keywords":715,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":720,"lastUpdatePostDateStruct":721,"startDateStruct":723,"completionDateStruct":725,"leadSponsor":727,"locationsCount":729},"100561258","a-biospecimen-collection-study-to-identify-the-targets-of-disease-reactive-t-cells-in-patients-with-autoimmune-disease-100561258","NCT06587828","A Biospecimen Collection Study to Identify the Targets of Disease-Reactive T Cells in Patients With Autoimmune Disease","Cohort Legend: Cohort 1: Inflammatory Bowel Diseases - Crohn's Disease or Ulcerative Colitis, Cohort 2: Celiac Disease, Cohort 3: Ankylosing spondylitis or non-radiographic axial spondyloarthritis (nr-axSpA), Cohort 4: Multiple Sclerosis, Cohort 5: Scleroderma, Cohort 6: Systemic Sclerosis with pulmonary involvement, Cohort 7: Other Autoimmune Disease, Cohort 8: Apparent Evolving Autoimmune Disease, Cohort 9: Frozen Cryopreserved\n\nInclusion Criteria:\n\n* Study cohorts 1,2,3,4,5,6,7,8.9: Known or suspected diagnosis, with subsequent diagnostic confirmation, of one of the following cohorts associated with the following autoimmune diseases:\n* Inflammatory Bowel Diseases - Crohn's Disease or ulcerative colitis\n* Celiac disease\n* Ankylosing spondylitis or Non radiographic axial spondyloarthritis (nr-axSpA)\n* Multiple sclerosis\n* Scleroderma\n* Systemic sclerosis with pulmonary involvement\n* Other autoimmune disease (as agreed between Investigator and Sponsor)\n* Apparent evolving autoimmune disease\n* Frozen cryopreserved\n* Age equal or greater than 18 years at time of informed consent.\n* Ability to understand and willingness to sign an informed consent document when informed consent is required by an ethical review board.\n* On disease-modifying treatments that are not known to be directly T cell toxic.\n\nSuch treatments are allowed and include:\n\n* Non-steroidal anti-inflammatory drugs including aspirin, ibuprofen, acetaminophen, celecoxib, indomethacin, diclofenac, etodolac, naproxen, meloxicam, sulindac, nabumetone amongst others.\n* Tumor necrosis factor alpha (TNF-alpha) antagonists including infliximab (Remicade), adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel), golimumab (Simponi) and biosimilar drugs with the same generic name.\n* Interleukin-12\u002F23 antagonists including ustekinumab (Stelara) and risankizumab-rzaa (Skyrizi)\n* Alpha-4-integrin antagonists including vedolizumab (Entyvio), natalizumab (Tysabri)\n* Interleukin-17 inhibitors including secukinumab (Cosentyx), ixekizumab (Taltz)\n* Recombinant interferon beta\n* CD20 antagonists including rituximab (Rituxan), ocrelizumab (Ocrevus), ofatumumab (Kesimpta)\n* Oral fumarates including dimethyl fumarate (Tecfidera), diroximel fumarate (Vumerity), monomethyl fumarate (Bafiertam)\n* Oral sphingosine 1-phosphate receptor (S1PR) modulators including fingolimod (Gilenya), siponimod (Mayzent), ozanimod (Zeposia), ponesimod (Ponvory)\n* Oral glatiramer acetate (copolymer 1; Copaxone)\n* Patient is an appropriate candidate for a procedure to obtain a biopsy, tissue samples or biologic materials during a clinically indicated procedure where it is expected that excess materials could be used for research OR\n* In the opinion of the clinical investigator, a patient is an appropriate, low-risk candidate for a research only procedure to obtain a biopsy, tissue samples or biologic materials.\n\nExclusion Criteria:\n\n* On treatment with drugs that are known to be T cell toxic and cannot be held for at least 4 weeks or longer. The following treatments are not allowed except in designated cohorts when approved by Sponsor:\n* Glucocorticoids including prednisone, methylprednisolone (Solu-medrol), budesonide (Entocort), hydrocortisone (Solu-cortef), dexamethasone (Decadron), betamethasone (Betaject)\n* Sulfasalazine (Azulfidine)\n* Aminosalicylates including mesalamine\u002F mesalazine (Asacol, Pentasa).\n* Thiopurines including azathioprine (Imuran) and 6-mercaptopurine (Purixan)\n* Systemic JAK inhibitors including tofacitinib (Xeljanz), abrocitinib (Cibinqo), baricitinib (Olumiant), upadacitinib (Rinvoq)\n* CD52 inhibitors including alemtuzumab (Campath)\n* Methotrexate\n* Cladribine\n* Teriflunomide (Aubagio)\n* Concurrent disease or condition that would make the patient inappropriate for study participation, or any serious medical or psychiatric disorder that would interfere with the subject's safety.\n* Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent.\n* Patients receiving research biopsy procedures will not have a history of serious or life-threatening allergic reaction to local anesthetics (i.e., lidocaine, xylocaine), if local anesthetic is required for the procedure or to medications used for sedation during a procedure.\n* Pregnant or nursing women are excluded because there may be unanticipated adverse events and increased risk to both mother and fetus in the setting of local anesthetic or study procedures.\n* Any other medical or psychiatric condition, which in the opinion of the patient's treating clinician, would make participation in this protocol unreasonably hazardous for the patient.",{"count":303,"type":22},"The most clinically meaningful way to discover new targets of T cells in autoimmune diseases is to study the tissues of patients with active autoimmune disease mediated organ inflammation. These tissues contain both cytotoxic and helper T cells that are driving their disease, and these T cells are being guided by TCRs that recognize tissue-specific targets. By collecting tissue when a patient has active inflammation, it is possible to determine which T cells are activated and undergoing clonal expansion in the patient's diseased organ. TScan has developed a genome-wide, high-throughput technology to determine the natural, physiological target of any TCR (Kula, 2019). The goal of this study is to isolate T cells from inflamed tissues and matched blood samples and\u002For matched normal tissues (for patients with inflammatory bowel diseases). T cell clones that are expanded in diseased tissues relative to blood or normal tissues will be selected and the targets of their TCRs will be defined using TScan's genome-wide, high-throughput target ID technology.\n\nThe goal of this study is to discover a collection of peptide targets, along with their associated TCRs to be developed as new tolerogenic therapies for patients with autoimmune diseases.",[344,709,651,710,711,28,712,713,714],"Ulcerative Colitis","Scleroderma","Ankylosing Spondylitis","Non-radiographic Axial Spondyloarthritis (Nr-axSpA)","Crohn&Amp;#39;s Disease","Birdshot Chorioretinitis",[344,651,716,711,710,717,718,719,714],"Systemic Sclerosis","Inflammatory Bowel Disease","Crohn's Disease","Non-radiographic axial spondyloarthritis (nr-axSpA)","2025-11-21",{"date":722,"type":37},"2025-11-24",{"date":724,"type":37},"2023-01-03",{"date":726,"type":22},"2027-01",{"name":728,"class":70},"TScan Therapeutics, Inc.",12,{"id":731,"slug":732,"hasResults":12,"nctId":733,"briefTitle":734,"officialTitle":735,"acronym":4,"eligibilityCriteria":736,"healthyVolunteers":12,"sex":18,"minAge":19,"maxAge":205,"enrollmentInfo":737,"targetDuration":4,"studyType":23,"phases":739,"briefSummary":740,"conditions":741,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":742,"lastUpdatePostDateStruct":743,"startDateStruct":745,"completionDateStruct":747,"leadSponsor":749,"locationsCount":45},"100591633","phase-2-randomized-double-blind-placebo-controlled-phase-2-study-in-adults-with-celiac-disease-100591633","NCT06982963","Randomized, Double Blind, Placebo-controlled Phase 2 Study in Adults With Celiac Disease","A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Efficacy and Safety of FB102 in Adult Participants With Celiac Disease on a Gluten Free Diet","Inclusion Criteria:\n\n1. Men and women aged 18 to 70 years at Screening.\n2. Has documented diagnosis of CeD confirmed by intestinal biopsy and positive celiac serology at least 12 months prior to Screening (intestinal biopsy and serology do not have to be performed concurrently).\n3. Body mass index (BMI) between 16.0 and 40.0 kg\u002Fm2, inclusive.\n4. Self-reported to be on a GFD for at least 12 months prior to Screening and must be willing to remain on a GFD for the duration of study participation, with the exception of the oral gluten challenge administered as a study procedure. Prior acute and resolved accidental exposures are not exclusionary.\n\nExclusion Criteria:\n\n1. Uncontrolled CeD and\u002For active signs\u002Fsymptoms of CeD, in the opinion of the Investigator.\n2. History of or current neuropsychiatric manifestations specifically related to gluten exposure including ataxia, seizures, severe peripheral neuropathy, cognitive impairment, and depression.",{"count":738,"type":22},100,[57],"This study is a randomized, double-blind, placebo controlled clinical study to assess the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of FB102 in adult participants with well controlled (on a strict GFD) CeD following an oral gluten challenge.",[28],"2025-11-17",{"date":744,"type":37},"2025-11-18",{"date":746,"type":37},"2025-08-04",{"date":748,"type":22},"2027-02-28",{"name":750,"class":70},"Forte Biosciences, Inc."]