[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"gut-microbiome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:gut-microbiome":30},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,42,0,25,[9,51,81,102,126,151,173,206,242,277,302,330,360,391,439,482,504,555,582,607,625,652,676,702,733],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":16,"eligibilityCriteria":17,"healthyVolunteers":18,"sex":19,"minAge":20,"maxAge":21,"enrollmentInfo":22,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":26,"conditions":27,"keywords":33,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100636600","gbpdc-gut-brain-in-pd-consortium-master-protocol-100636600",false,"NCT07567794","GBPDC: Gut-Brain in PD Consortium Master Protocol","Consortium for Gut-Brain Communication in Parkinson's Disease Master Protocol","GBPDC","Inclusion Criteria (All PD Cohorts)\n\n1. Aged ≥21 years old and ≤80 years old\n2. Clinical diagnosis of PD as defined by Movement Disorder Society (MDS) PD Criteria\n3. Adequate visual, hearing, cognitive, and physical ability\n4. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures. Because longitudinal participation is important to the scientific goals of the program, a \"best estimate\" of interest, commitment, and geographic feasibility for three years will be documented by the enrolling investigator after interview with the potential enrollee\n\nInclusion Criteria Controls\n\n1. Aged ≥21 years old and ≤80 years old\n2. No known or diagnosed neurodegenerative disease\n3. Willingness and ability to comply with scheduled visits, laboratory tests, and other study procedures\n4. Resides within the same household as person with PD\n\nInclusion Criteria Prodromal Cohort\n\n1. Aged ≥21 years old and ≤80 years old\n2. Prodromal characteristics are defined by the MDS Research Criteria for PD and include either polysomnography (PSG)-confirmed rapid eye movement sleep behavior disorder (RBD) or possible RBD (questionnaire-based), with hyposmia as defined by the University of Pennsylvania Smell Identification Test (UPSIT) ≤ 15th percentile.\n\nExclusion Criteria (All Cohorts)\n\n1. Diagnosis of secondary or atypical parkinsonism\n2. Laboratory Values:\n\n   1. Hemoglobin (Hgb) \\\u003C10\n   2. Platelets \\\u003C70,000\n   3. Alanine Transaminase (ALT) or Aspartate Aminotransferase (AST) \\> 2 1\u002F2 times upper limit of normal (ULN)\n   4. Moderate or severe renal disease with an estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002FBSA \\[body surface area\\]) calculated using the Chronic Kidney Disease-Epidemiology Collaboration (CKD-EPI) equation, or moderate or severe hepatic impairment (alkaline phosphatase \\[ALP\\] \\>2.0 times the ULN and\u002For total bilirubin \\>2.0 times the ULN)\n   5. Significantly above the normal range for PT\u002FINR\u002FPTT\n3. Currently taking anticoagulants that are deemed exclusionary by the investigator for risk of bleeding with sigmoidoscopy procedure\n4. Clinically significant cognitive impairment with a Montreal Cognitive Assessment (MOCA) score \\\u003C22\n5. Clinical or laboratory findings consistent with another primary neurodegenerative disease or cognitive disorder other than PD, including but not limited to, frontotemporal lobar disease, Huntington's disease, progressive supranuclear palsy, multisystem atrophy, Creutzfeld-Jakob- Disease, Down's syndrome, cortico-basal degeneration, dementia with Lewy Bodies, Alzheimer's disease, amyotrophic lateral sclerosis, seizure disorder, stroke, or other infectious, metabolic, or systemic disease affecting the central nervous system including, but not limited to, syphilis, present hypothyroidism, present or unaddressed\u002Ftreated vitamin B12 deficiency, or other screening laboratory abnormalities\n6. Suicidality, defined as active suicidal thoughts or ideation within 6 months before Screening or at Baseline, defined as answering yes to items 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS), or history of suicide attempt in previous 2 years, or, in the Investigator's opinion, at serious risk of suicide\n7. Has cancer or has had a malignant tumor within the past 5 years. (Participants with stable untreated prostate cancer or treated\u002Fremoved cutaneous carcinomas are not excluded.)\n8. Any medical condition or systemic disease that, in the Investigator's opinion, may either put the participant at risk because of participation in the study, influence the results or proposed analyses, or impair the participant's ability to fully participate in the study\n9. Body mass index (BMI) \\>35 kg\u002Fm2 or body weight \\\u003C50 kg\n10. Participant is currently pregnant, breastfeeding, and\u002For lactating\n11. History of alcohol or substance abuse or dependence within the past 2 years (DSM IV criteria)\n12. History of Covid 19 (SARS-CoV-2) infection within 6 weeks prior to screening.\n13. Participants with unresolved symptoms of Covid 19 infection or ongoing cognitive or other deficits attributable to post-Covid 19 that may affect participant safety or interfere with cognitive assessments based on the Investigator's clinical judgment\n14. Either ongoing or current participation in another clinical trial with an investigational agent and have taken at least one dose of study medication, unless unblinded on placebo, within 4 weeks prior to the start of screening, or five half-lives of the investigational drug, whichever is greater. The end of a previous investigational trial is the date the last dose of an investigational agent was taken. Participation in other research studies (e.g., observational studies) may be acceptable throughout this study.\n15. History of GI surgery. (However, patients with appendicectomy, hemorrhoid surgery, and cholecystectomy will be eligible to participate).\n16. Regular use of medication that impacts the intestinal barrier (e.g., NSAID more than 3 times weekly)\n17. Has a history of Crohn's disease, ulcerative colitis, and\u002For other types of colitis (microscopic, lymphocytic, or collagenous colitis). Confirmed diagnosis of inflammatory bowel disease (IBD) and\u002For, active or uncontrolled IBD symptoms such as diarrhea, bleeding, or severe stomach pain. Treatment for IBD in the past 6 months with medicines such as steroids, biologics, or strong immune-suppressing drugs. Surgery to remove part of the bowel due to IBD. Other long-term gut diseases that cause inflammation, such as celiac disease.",true,"ALL","21 Years","80 Years",{"count":23,"type":24},250,"ESTIMATED","OBSERVATIONAL","The purpose of this research study is to identify the role that the gut-brain axis, the group of nerves that connect the brain and gut, plays in Parkinson's disease (PD). The National Institute of Diabetes and Digestive and Kidney Diseases is sponsoring this research study.\n\nDuring this study, specific groups of participants, also known as \"cohorts\", will be identified based on the severity of their PD. There will also be a cohort enrolling participants who do not have Parkinson's and a cohort enrolling participants that are at risk for developing PD. Each of these cohorts will be compared to the others to assess the differences in the gut-brain connection.\n\nParticipants in this study will:\n\n* meet with a medical provider\n* answer questionnaires\n* give samples of blood, stool, and saliva\n* have X-rays taken while swallowing different foods (swallowing study)\n* have X-rays taken to see how long it takes markers to move through their colon (colon transit study)\n* have a flexible sigmoidoscopy, where a doctor looks inside the lower part of the colon and takes small tissue samples (biopsies) from the mucosa (lining)\n* have samples taken of their skin\n* have an anorectal manometry and a balloon expulsion test, where a small tube and balloon are placed in the rectum to measure muscle function.\n\nParticipation in the study will last up to 24 months (2 years).",[28,29,30,31,32],"Parkinson Disease (PD)","PARKINSON DISEASE (Disorder)","Gut Microbiome","Gut Microbiota","Prodromal Parkinsons Disease",[34,35,36,37],"gut brain","Parkinson's disease","Prodromal Parkinson's disease","healthy control","RECRUITING","2026-08-20",{"date":41,"type":42},"2026-08-21","ACTUAL",{"date":44,"type":42},"2026-07-03",{"date":46,"type":24},"2028-12-31",{"name":48,"class":49},"Duke University","OTHER",7,{"id":52,"slug":53,"hasResults":12,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":4,"eligibilityCriteria":57,"healthyVolunteers":18,"sex":19,"minAge":58,"maxAge":59,"enrollmentInfo":60,"targetDuration":4,"studyType":62,"phases":63,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":71,"lastUpdatePostDateStruct":72,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100652904","effects-of-probiotic-supplementation-on-gut-health-immune-response-and-well-being-100652904","NCT07779265","Effects of Probiotic Supplementation on Gut Health, Immune Response, and Well-Being","Randomized, Double-Blind, Placebo-Controlled Exploratory Study Assessing the Effects of Probiotic Supplementation on Gut Barrier Function, Immune Response, and Well-Being.","Inclusion Criteria:\n\n* Volunteer is healthy at the time of screening according to participant's own statements.\n* TICS SSCS score ≥ 6.\n* Male or female aged ≥18 and ≤65 years at the time of screening.\n* BMI ≥18.5 and ≤29.9 kg\u002Fm².\n* Volunteer is able and willing to comply with the study instructions.\n* Volunteer is suitable for participation in the study according to the investigator\u002Fstudy personnel.\n* Voluntary, written informed consent to participate in the study.\n\nExclusion Criteria:\n\n* No command of local language.\n* Currently diagnosed neurological or psychiatric disorders.\n* Gastrointestinal disorders including irritable bowel syndrome (IBS), inflammatory bowel disease (IBD) or other conditions that might affect the gut environment.\n* Contraindication or allergy to any ingredient in the verum or Placebo product.\n* Use of drugs in the previous 4 weeks before the beginning of intervention.\n* Use of laxatives and labelled pre#and probiotics in the previous 2 weeks before the beginning of intervention.\n* Participation in another study with any investigational product within 30 days of screening, or less than five elimination half-lives after the last administration of the investigational product (whichever period is longer) or during the study.\n* History of drug (recreational) or alcohol abuse.\n* Bowel preparation for investigative procedures in the 4 weeks prior to screening.\n* Surgical resection of any part of the bowel (excl. appendectomy).\n* Pregnant or lactating female, or pregnancy planned during study period, or women of childbearing potential who are not using a medically approved form of contraception (at least three months prior to screening).\n* Regular smoking.","18 Years","65 Years",{"count":61,"type":24},50,"INTERVENTIONAL",[64],"NA","This randomized, double-blind, placebo-controlled exploratory study will evaluate the effects of daily probiotic supplementation on gut barrier function, immune-related markers, and well-being in healthy adults with mild to moderate perceived stress.\n\n50 participants will be randomly assigned to receive either a probiotic supplement or placebo for 8 weeks. Blood and stool samples will be collected before and after the intervention to assess markers of gut barrier function, intestinal inflammation, gut microbiome composition, short-chain fatty acids, and immune function. Participants will also complete questionnaires on stress, quality of life, mood, digestive symptoms, and bowel habits. Safety will be evaluated throughout the study by monitoring adverse events and vital sign assessments.",[30,67,68],"Immune Responses","Well-being",[70],"RCT, Gut Barrier Function, Immune Response, Well-Being","2026-08-19",{"date":41,"type":42},{"date":74,"type":42},"2026-08-13",{"date":76,"type":24},"2026-12",{"name":78,"class":79},"Orthomol Pharmazeutische Vertiebs GmbH","INDUSTRY",1,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":87,"eligibilityCriteria":88,"healthyVolunteers":12,"sex":19,"minAge":58,"maxAge":4,"enrollmentInfo":89,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":80},"100531952","the-gut-microbiome-and-serum-metabolites-as-a-biological-mechanism-underlying-pain-in-kidney-transplantation-100531952","NCT06206486","The Gut Microbiome and Serum Metabolites as a Biological Mechanism Underlying Pain in Kidney Transplantation","The Gut Microbiome and Serum Metabolites as a Biological Mechanism Underlying Pain in Kidney Transplantation (Biome-KT)","BIOME-KT","Inclusion Criteria:\n\n* Receiving a kidney transplant at the University of Illinois Hospital \\& Health Sciences System (UI Health) Transplant Center at the University of Illinois Chicago (UIC),\n* Planning to receive a kidney transplant at the UI Health Transplant Center\n* 18 years of age or older (adult), and\n* Understand the study process and provide written informed consent to participate.\n\nExclusion Criteria:\n\n* Having a history of colon cancer or an inflammatory bowel disease\n* Planning to receive a multiorgan transplant (e.g., simultaneous pancreas and kidney transplant).\n* Having a history of Clostridium difficile infection in the preceding 8 weeks.",{"count":90,"type":24},133,"Study Summary Nearly half (47%) of people with end-stage kidney disease (ESKD) whose kidney function is restored after kidney transplantation experience chronic pain compared to 19% of adults in the US general population. Pain is associated with comorbid fatigue, depression and anxiety, and withdrawal from usual physical and social activities; resulting in an inability to participate in and enjoy life. Severe pain can result in nonadherence to immunosuppression and treatment protocols and result in an increased risk of rejection, graft loss, and mortality. The role of symbiotic microbes (microbiota) in the gastrointestinal tract, and their functional genes (microbiome), is well established in diseases involving pain. Diet and stress play a major role in synthesis of signaling molecules critical to immunologic, metabolic, and endocrine pathways regulating chronic pain. Dietary patterns change dramatically after transplantation, as recipients move from a restricted \"renal\" diet to a regular diet, often resulting in increased consumption of foods high in sugars and fat. Moreover, psychological stress significantly impairs the function of the microbiome, initiating biological pathways involved in pain, leading to a disproportionate pain burden. Because the microbiome, serum metabolites, and pain are dynamic, our novel investigation will employ a prospective repeated measures design to interrogate the dynamic temporal relationships between the microbiome, metabolites associated with pathways regulating pain, transplantation factors (e.g. immunosuppression, kidney function), changing dietary patterns, and perceived stress, on pain scores before and after kidney transplantation. The investigators posit the gut microbiome, and its byproducts, may partially explain the underlying biological mechanisms of pain Interference in kidney disease. The investigators will address three aims: 1) To determine differential dynamic temporal relationships between microbial composition\u002Ffunctional genes and circulating serum metabolites in KTRs with pain vs no pain, 2) To determine the moderation effects of diet and perceived stress on dynamic temporal relationships between microbiome features, serum metabolites, and pain scores among KTRs, and 3) To use machine learning algorithms to identify host-microbial interactions that are causally linked to pain interference among KTRs. Because kidney function is restored, the kidney transplant model is powerful to study the longitudinal relationships between the microbiome, circulating metabolites and chronic pain in people with ESKD to develop patient-centered interventions to treat pain across the spectrum of CKD.",[93,30],"Kidney Transplant Symptoms",{"date":95,"type":42},"2026-08-17",{"date":97,"type":42},"2023-10-09",{"date":99,"type":24},"2028-03",{"name":101,"class":49},"University of Illinois at Chicago",{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":107,"acronym":4,"eligibilityCriteria":108,"healthyVolunteers":12,"sex":19,"minAge":109,"maxAge":110,"enrollmentInfo":111,"targetDuration":4,"studyType":62,"phases":113,"briefSummary":114,"conditions":115,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":80},"100446194","the-path-study-cognitive-and-inflammation-targeted-gut-brain-interventions-in-alcohol-probiotics-alcohol-transcutaneous-vagus-nerve-stimulation-and-hiv-study-100446194","NCT05090267","The Path Study: Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study","Cognitive and Inflammation Targeted Gut-brain Interventions in Alcohol; Probiotics, Alcohol, Transcutaneous Vagus Nerve Stimulation, and HIV Study","Inclusion Criteria:\n\n* Age 35-70 years\n* English or Spanish speaking\n* Alcohol users\n* Cognitive impairment\n* Current CD4\\>350\n\nExclusion Criteria:\n\n* Diagnosed major psychiatric illness\n* Consumption of over 300 drinks in the past 30 days\n* Recent opioid use\n* Lifetime history of medically-assisted alcohol detoxification\n* Inpatient or intensive treatment for addictive behaviors in the past 12 months\n* MRI contraindications\n* Current antibiotic treatment\n* Current probiotic use\n* Physical impairment precluding motor response or lying still.","35 Years","70 Years",{"count":112,"type":24},80,[64],"This project uses a hybrid trial design to evaluate two biomedical interventions targeting the gut-brain axis. One intervention is portable Transcutaneous Vagus Nerve Stimulator, tVNS, that is hypothesized to stimulate the autonomic nervous system, resulting in decreased inflammation and improved cognition. The second intervention is a probiotic supplement intended to replace gut bacteria that are associated with dysbiosis in persons with HIV and alcohol consumption.",[116,30],"Cognition","2026-08-04",{"date":119,"type":42},"2026-08-06",{"date":121,"type":42},"2022-06-01",{"date":123,"type":24},"2026-12-30",{"name":125,"class":49},"University of Florida",{"id":127,"slug":128,"hasResults":12,"nctId":129,"briefTitle":130,"officialTitle":131,"acronym":132,"eligibilityCriteria":133,"healthyVolunteers":18,"sex":19,"minAge":58,"maxAge":4,"enrollmentInfo":134,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":136,"conditions":137,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":80},"100643532","gut-leakage-in-dengue-100643532","NCT07602920","Gut Leakage' in Dengue","Gut Leakage and Sonographic Abdominal Changes in Hospitalized Dengue Patients: an Observational Study","GLiD","Inclusion Criteria:\n\nDengue participants\n\n* Participant\u002F legally authorised representative willing and able to give informed consent for participation in the study.\n* Male or Female, adults ≥18 years\n* Diagnosed as a case of Dengue on the basis of clinical features and positive NS1 antigen and\u002For IgM dengue antibody\n* Hospitalized in medicine or dengue ward in Chittagong Medical College Hospital.\n* Enrolled within 24 hours of hospitalization.\n\nHealthy participants\n\n* Participant\u002F legally authorised representative willing and able to give informed consent for participation in the study.\n* Male or Female, adults ≥18 years\n* Clinically healthy with no acute or chronic illness\n* Attendant of a dengue patient (not a patient)\n\nExclusion Criteria:\n\nDengue participants\n\n* Unable to provide consent or participate in follow-up procedures\n* Known chronic gastrointestinal (GI) disease affecting intestinal permeability (IBD, celiac disease), chronic liver disease, active chronic diarrhoea, short bowel loop syndrome, recent (\\\u003C3 months) major GI surgery.\n* Immunosuppression (for example chemotherapy, high-dose steroids), advanced chronic kidney disease, decompensated heart failure.\n* Drugs that can alter the level of biomarkers in blood like metformin, statin, probiotics, steroid within last 48 hours of hospitalization.\n* Pregnancy\n\nHealthy participants\n\n* Unable to provide consent\n* Known chronic gastrointestinal (GI) disease affecting intestinal permeability (IBD, celiac disease), chronic liver disease, active chronic diarrhoea, short bowel loop syndrome, recent (\\\u003C3 months) major GI surgery.\n* Immunosuppression (for example chemotherapy, high-dose steroids), advanced chronic kidney disease, decompensated heart failure.\n* Drugs that can alter the level of biomarkers in blood like metformin, statin, probiotics, steroid within last 48 hours of hospitalization.\n* Pregnancy\n* History of current or recent dengue or other arbo viral infection",{"count":135,"type":24},190,"Dengue infections are imposing an increasing global burden of disease, particularly in tropical countries such as Bangladesh. The World Health Organization (WHO) has identified Dengue virus as a priority pathogen for the development of medical counter measures because of the high risk of it causing a Public Health Emergency of Intenational Concern (PHEIC). Warning signs for severe dengue, associated with mortality, include gastrointestinal features including abdominal pain, vomiting, and diarrhoea. Multiple alterations may occur in in the gastrointestinal tract that could lead to damaging of the gastrointestinal wall and gut leakage, the translocation of gut metabolites into the bloodstream. Study team hypothesize that gut leakage initiates inflammatory processes underlying the further development of severe dengue, including features associated with plasma leakage.\n\nThis study aims to investigate intestinal barrier dysfunction (gut leakage) in dengue infection by detecting the translocation of gut-derived bacteria and their products (Lipopolysaccharides, LPS binding protein, sCD14, I-Fatty Acid Binding Protein) into the bloodstream. Study team will recruit hospitalized adult dengue patients (18 years and older) presenting with warning signs or severe disease in a tertiary care public hospital at Chattogram, Bangladesh. Circulating biomarkers indicative of gut permeability and microbial translocation will be measured to assess their presence and association with disease severity.\n\nAbdominal ultrasonography will be performed to characterize gastrointestinal alterations and determine their correlation with biochemical markers of gut leakage and clinical severity. In addition, study team will analyze the gut bacteriome from stool\u002F rectal swab of these patients to explore whether dengue infection induces compositional changes in intestinal microbiota and whether such alterations are linked to gut leakage or disease progression.",[138,139,140,141,142,30],"Dengue","Dengue Hemorrhagic Fever","Intestinal Disease","Ascites","Dengue With Warning Signs","2026-08-03",{"date":119,"type":42},{"date":146,"type":42},"2026-08-01",{"date":148,"type":24},"2028-01-31",{"name":150,"class":49},"University of Oxford",{"id":152,"slug":153,"hasResults":12,"nctId":154,"briefTitle":155,"officialTitle":155,"acronym":156,"eligibilityCriteria":157,"healthyVolunteers":18,"sex":19,"minAge":58,"maxAge":4,"enrollmentInfo":158,"targetDuration":4,"studyType":62,"phases":160,"briefSummary":161,"conditions":162,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":166,"completionDateStruct":168,"leadSponsor":170,"locationsCount":80},"100588414","nutrition-gut-microbiota-and-health--feces-sample-collection-in-nutrinet-sant-participants-100588414","NCT06941090","Nutrition, Gut Microbiota and Health : Feces Sample Collection in NutriNet-Santé Participants","NUTRIGUT","Inclusion Criteria:\n\n* Participant in the NutriNet-Santé cohort\n* Age ≥ 18 years\n* Resident of metropolitan France\n* Written comprehension frenc\n\nExclusion Criteria:\n\n* Person subject to a safeguard of justice measure\n* Person belonging to one of the categories of vulnerable persons\n* Diagnosis of COVID-19 (clinically or by PCR) in the month prior to collection\n* Contact with a COVID-19 patient in the month prior to collection\n* Suspicion of COVID-19 in the month preceding collection (clinical signs of infection : fever associated with headache, respiratory signs, os anosmia\u002Fageusia)",{"count":159,"type":24},10000,[64],"The gut microbiota is currently attracting increasing attention from the scientific community and also from the general public, as evidence of its role in human physiology has been highlighted. Microbial signatures have also been associated with various pathologies (e.g. obesity, diabetes, gastrointestinal disorders, neurodegenerative diseases), but the causality of these associations is still uncertain. Among the factors that may influence the composition of the gut microbiota (e.g. lifestyle, hygiene, medication, genetics, environment), nutrition would a major role. The major changes in lifestyle and diet observed over recent decades are strongly suspected of disrpting the host-gut microbiota balance.\n\nIn addition to their nutrient content, our diets also contain other bioactive compounds (e.g. polyphenols) and raise new issues (e.g. temporal structure of diets, food processing, presence of additives or contaminants such as pesticide residues, intake of dietary supplements, dietary exclusions, glycemic index) that is necessary to take into account. Thus, it is mandatory to explore and characterize in a more precise way, within large samples consisting of individuals with varied characteristics, the way in which the composition of the gut microbiota is influenced by the host's diet and its health consequences.\n\nThe aim of this research is therefore to study the links between nutrition, gut microbiota profiles and health. To do this, the research will implement large-scale stool sample collection from participants in the NutriNet-Santé cohort (\"Nutrinautes\"), thus constituting a \"microbiota\" sub-cohort.\n\nA target of N=10,000 participants in the NutriNet-Santé cohort will be recruited on a voluntary basis. A selection will then be made among Nutrinautes willing to participate in the research (which may be more numerous than necessary) to maximize the diversity of profiles. Participants will be informed of their selection or non-selection by e-mail. A second stool sample will also be collected 2-3 months after the first for a sub-sample of N=300 to assess intra-individual variability in microbiota profiles. The selected participants will receive a stool self-sampling kit with detailed instructions by post to their home address. The pseudonymized samples will be returned by mail by the participant to the processing laboratory, which will determine their gut microbiota characteristics by 16S rDNA sequencing and\u002For \" shotgun \" sequencing. The gut microbiota profiles will then be analyzed in a pseudonymised manner in association with diet and health, using data collected as part of the NutriNet-Santé cohort follow-up (e.g. food consumption, prevalence and incidence of pathologies, biological data, anthropometric characteristics, medication intake, socio-demographic characteristics, lifestyle).",[30],"2026-07-30",{"date":165,"type":42},"2026-07-31",{"date":167,"type":42},"2023-12-15",{"date":169,"type":24},"2033-12-15",{"name":171,"class":172},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV",{"id":174,"slug":175,"hasResults":12,"nctId":176,"briefTitle":177,"officialTitle":178,"acronym":4,"eligibilityCriteria":179,"healthyVolunteers":18,"sex":180,"minAge":181,"maxAge":110,"enrollmentInfo":182,"targetDuration":4,"studyType":62,"phases":184,"briefSummary":186,"conditions":187,"keywords":190,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":80},"100621045","phase-1-blackcurrants-modify-gut-microbiota-and-reduce-osteoporosis-risk-in-postmenopausal-females-100621045","NCT07365514","Blackcurrants Modify Gut Microbiota and Reduce Osteoporosis Risk in Postmenopausal Females","Blackcurrants Mitigate Postmenopausal Bone Loss Through Gut Microbiota-Bone Axis: A Randomized Clinical Trial Coupled With a Multi-Omics Approach to Inform Precision Nutrition","Inclusion Criteria:\n\n* postmenopausal (defined as no more than 10 years since final menstrual cycle) females aged 45-70 years\n* not on hormone replacement therapy for at least one year before initiation of the study\n* maintaining normal exercise level (\\\u003C 7 hours\u002Fweek) and willing to avoid exercise for 24 hours prior to blood and stool sampling\n* willing to ingest a dietary blackcurrant supplement or placebo (up to 1,176 mg\u002Fday, three 392mg capsules)\n* willing to avoid other dietary supplements for the duration of the study\n* willing to avoid intake of foods extremely rich in anthocyanins and fermented dairy products containing viable Bifidobacteria or Lactobacilli\n* willing to have three blood draws, three stool collections, and three bone scans\n\nExclusion Criteria:\n\n* history of cardiovascular disease, osteoporosis, metabolic bone disease, cancer, diabetes mellitus, arthritis, or other chronic inflammatory diseases\n* current smokers\n* taking prescription medications known to alter bone and calcium metabolism\n* taking anabolic agents such as parathyroid hormone or growth hormone, or steroid within 3 months before the start of the study\n* taking medications that alter bleeding (such as antiplatelets or anticoagulants) or those with a bleeding disorder\n* alcohol consumption exceeding 2 drinks\u002Fday (approximately 14g of ethanol per drink) or a total of 12\u002Fweek\n* those with planned surgery during the study period or within 2 weeks of ending the intervention\n* those with sensitivities or allergies to any of the ingredients for the placebo (rice powder)\n* planning a procedure that includes iodine, barium or nuclear medicine isotopes within the study period\n* UConn students and\u002For employees who any key personnel teach or who report to any key personnel\n* study key personnel, partners of key personnel, or dependents\u002Frelatives of any key personnel","FEMALE","45 Years",{"count":183,"type":24},159,[185],"PHASE1","The goal of this clinical trial is to evaluate the effects of blackcurrant (BC) supplementation on changes in bone density and gut microbiome composition in postmenopausal females.",[188,30,189],"Postmenopausal Osteoporosis","Menopause",[191,192,193,194,195,196],"blackcurrant","gut microbiome","osteoporosis","menopause","females","bone aging","2026-07-21",{"date":199,"type":42},"2026-07-23",{"date":201,"type":24},"2026-07",{"date":203,"type":24},"2029-09",{"name":205,"class":49},"University of Connecticut",{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":210,"acronym":211,"eligibilityCriteria":212,"healthyVolunteers":18,"sex":19,"minAge":58,"maxAge":59,"enrollmentInfo":213,"targetDuration":4,"studyType":62,"phases":215,"briefSummary":216,"conditions":217,"keywords":222,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":233,"lastUpdatePostDateStruct":234,"startDateStruct":236,"completionDateStruct":238,"leadSponsor":240,"locationsCount":80},"100646313","combining-fasting-and-fibre-interventions-to-optimise-their-gut-microbiome-mediated-health-benefits-100646313","NCT07691736","Combining Fasting and Fibre Interventions to Optimise Their Gut Microbiome-mediated Health Benefits","CoFFIe","Inclusion Criteria:\n\n* Men and women\n* Age: 18-65 years old\n* Fasting for 10±4 days at the Buchinger Wilhelmi clinic in Überlingen\n* BMI ≥ 25 kg\u002Fm²\n* Signed informed consent\n\nExclusion Criteria:\n\n* intake of antibiotics up to 2 months prior the study\n* regular intake of pre-, post- and probiotics up to 2 months prior the study\n* diagnosed Crohn's disease, Ulcerative colitis, IBD, coeliac disease\n* medicated high blood pressure\n* diagnosed diabetes mellitus type I\n* medicated diabetes mellitus type II\n* diagnosed kidney stone\n* active malignant disease\n* known substance addiction\n* pregnancy or breastfeeding\n* diagnosed with cachexia, anorexia nervosa, advanced kidney, liver or cerebrovascular insufficiency\n* inability to sign the informed consent\n* participation in another study",{"count":214,"type":24},75,[64],"This study builds on the knowledge that fasting provides metabolic health benefits and that prebiotic interventions can enhance the gut microbiome's metabolic output to likewise improve host health. Whether long-term fasting and dietary fibre interventions could be combined to achieve synergistic improvements in host metabolic health is however unknown. The goal is to provide a proof of concept in a human trial that supplementing 10±4 days fasting with dietary fibre synergistically improves metabolic outcomes via gut microbiome-mediated effects. To assess this, we aim to analyse gut microbiome changes, functional outputs, and key metabolic markers such as butyrate production, glycaemic control and ketosis.\n\nThe randomised controlled trial includes 75 participants and has two arms: one involving fasting with fibre supplementation (n = 50) and one involving fasting without fibre supplementation (n = 25). All participants will undergo a fasting period of 10±4 days according to the Buchinger Wilhelmi protocol, followed by a stepwise reintroduction of food of up to 4 days. As dietary fibre we will use maize-derived resistant starch type IV, selected based on its ability to stimulate beneficial gut microbes like Oscillibacter and corn starch as placebo. Two main visits will be conducted: before and at the end of the fasting period. During these visits, blood and stool samples will be collected, and questionnaires will be completed. Additionally, daily measurements of anthropometric parameters and well-being will be recorded. Stool samples will also be collected one month afterwards as a follow-up. Participants' metabolic health will be evaluated through various clinical parameters (e.g., body measurements, blood pressure, glycaemic control, ketones, well-being). Additionally, multi-omics data, including metagenomics and metabolomics, will provide insight into the composition of the microbiome, as well as its outputs and functions. Furthermore, the effects of fasting on extracellular vesicles in blood will be explored.",[218,219,30,220,221],"Fasting","Dietary Fibre","Metabolism Changes","Overweight , Obesity",[223,224,225,226,192,227,228,229,230,231],"long-term fasting","fasting","continuous glucose monitoring","fibre supplementation","metabolic health","resistant starch IV","metabolomics","ketosis","extracellular vesicles","NOT_YET_RECRUITING","2026-07-02",{"date":235,"type":42},"2026-07-09",{"date":237,"type":24},"2026-09-01",{"date":239,"type":24},"2027-03",{"name":241,"class":49},"Buchinger Wilhelmi Development & Holding GmbH",{"id":243,"slug":244,"hasResults":12,"nctId":245,"briefTitle":246,"officialTitle":247,"acronym":248,"eligibilityCriteria":249,"healthyVolunteers":18,"sex":180,"minAge":250,"maxAge":4,"enrollmentInfo":251,"targetDuration":4,"studyType":62,"phases":253,"briefSummary":254,"conditions":255,"keywords":260,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":269,"lastUpdatePostDateStruct":270,"startDateStruct":271,"completionDateStruct":273,"leadSponsor":275,"locationsCount":4},"100645319","diabetes-insulin-gut-enteric-supplementation-trial-100645319","NCT07682077","Diabetes, Insulin, Gut, Enteric Supplementation Trial","Effects of a Kefir Intervention in Pregnancy on Glucose, Insulin, Gestational Diabetes Mellitus, and the Gut Microbiome and Metabolites: A Randomized Controlled Trial","DIGEST","Inclusion Criteria:\n\n* Pregnant individual with a singleton pregnancy\n* 19 years and older of age\n* Gestational age 14,3 weeks or less at enrolment\n* Able and willing to attend four in-person study visits at the PEADS Laboratory: baseline, 18-20 weeks' gestation, 26-28 weeks' gestation, and 1 month postpartum\n* Willing and able to comply with study group assignment, including daily consumption of 250 mL of kefir if assigned to the intervention group\n* Willing to avoid kefir consumption until completion of the 26-28-week study visit if assigned to the control group\n* Willing to provide required biological and clinical samples, including stool samples and glucose\u002Finsulin data, according to the study protocol\n* No probiotic, prebiotic, synbiotic, or antibiotic use during the first trimester or at enrollment\n* Not currently consuming probiotic, prebiotic, synbiotic, or antiobiotic supplements\n* Willing to avoid probiotic, prebiotic, and synbiotic supplements until completion of the 26-28-week study visit.\n* Does not engage in regular moderate-to-vigorous physical activity\n* No recent or active infectious illness or significant gastrointestinal symptoms, including diarrhea or constipation in the first trimester of pregnancy.\n* No history of bariatric surgery\n* Able to communicate in English or French\n* Currently living in Fredericton, New Brunswick, and not planning to relocate before the 1-month postpartum visit\n\nExclusion Criteria:\n\n* Pre-existing metabolic disease affecting glucose regulation, including type 1 diabetes or type 2 diabetes\n* Current use or first trimester use of medications known to alter glucose metabolism, such as metformin or semaglutide\n* Gastrointestinal or inflammatory disease, including Crohn's disease, ulcerative colitis, celiac disease, or diagnosed irritable bowel syndrome\n* Allergy, intolerance, or other contraindication to dairy or components of kefir","19 Years",{"count":252,"type":24},60,[64],"Pregnancy is a critical window for metabolic health, and early changes in blood sugar regulation can increase the risk of gestational diabetes mellitus (GDM), which affects both maternal and infant health. At the same time, the maternal gut microbiome changes throughout pregnancy and may play a role in glucose metabolism and insulin resistance. Kefir, a fermented milk drink containing beneficial bacteria and yeasts, may be a simple dietary strategy to support metabolic health during pregnancy, but its role in preventing GDM has not been well studied.\n\nThis study will test whether drinking kefir daily from mid-pregnancy until routine GDM screening can improve glucose and insulin regulation, reduce the incidence of GDM, and modulate the maternal gut microbiome and metabolites, among other outcomes.\n\nPregnant individuals will be randomly assigned to either a kefir group or a control group receiving usual prenatal care. Researchers will collect blood glucose and insulin measures, dietary information, stool samples, and body composition data across pregnancy and postpartum to evaluate metabolic and microbiome-related changes.\n\nAs one of the first studies to examine kefir as an early pregnancy intervention for GDM prevention, this study will help clarify whether a practical, food-based approach can improve maternal metabolic health. The findings may support future nutrition strategies aimed at reducing GDM risk and improving pregnancy outcomes.",[256,257,258,30,259],"Gestational Diabetes Mellitus (GDM)","Blood Glucose","Insulin Resistance, Diabetes","Gut Metabolites",[261,262,263,264,265,266,267,268],"Gestational diabetes mellitus","Pregnancy","Probiotics","Kefir","Gut microbiome","Gut metabolites","Glucose","Insulin","2026-06-30",{"date":233,"type":42},{"date":272,"type":24},"2026-06-01",{"date":274,"type":24},"2029-06-01",{"name":276,"class":49},"University of New Brunswick",{"id":278,"slug":279,"hasResults":12,"nctId":280,"briefTitle":281,"officialTitle":281,"acronym":4,"eligibilityCriteria":282,"healthyVolunteers":18,"sex":19,"minAge":58,"maxAge":4,"enrollmentInfo":283,"targetDuration":4,"studyType":62,"phases":285,"briefSummary":287,"conditions":288,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":293,"lastUpdatePostDateStruct":294,"startDateStruct":296,"completionDateStruct":298,"leadSponsor":300,"locationsCount":80},"100549384","phase-4-understanding-the-efficacy-of-dietary-supplement-on-fungal-mycobiota-in-healthy-volunteers-a-pilot-study-100549384","NCT06433310","Understanding the Efficacy of Dietary Supplement on Fungal Mycobiota in Healthy Volunteers: A Pilot Study","Inclusion Criteria:\n\n* Male or female adults over the age of 18 years\n\nExclusion Criteria:\n\n* History of a diagnosis of any gastrointestinal condition, such as inflammatory bowel syndrome or disease\n* Antibiotic usage within the past two weeks\n* Antifungal usage within the past month\n* Allergy to L-Phenylalanine or individuals with phenylketonuria (PKU)\n* Adults taking medications known to interact with L-phenylalanine supplements, such as Monoamine Oxidase Inhibitors (MOAI), L-DOPA, and some antipsychotic drugs (complete and extensive drug list will be provided to interested participants during screening)\n* Pregnant or nursing women",{"count":284,"type":24},20,[286],"PHASE4","The purpose of this study is to explore how the dietary supplement L-Phenylalanine affects the production of the metabolite phenylpropionic acid (PPA) and changes fungal populations of the gut microbiome.",[30,289,290,291,292],"Gut Health","Dietary Supplement","L-Phenylalanine","Phenylpropionic Acid","2026-06-23",{"date":295,"type":42},"2026-06-26",{"date":297,"type":42},"2024-10-17",{"date":299,"type":24},"2027-12-31",{"name":301,"class":49},"Weill Medical College of Cornell University",{"id":303,"slug":304,"hasResults":12,"nctId":305,"briefTitle":306,"officialTitle":307,"acronym":308,"eligibilityCriteria":309,"healthyVolunteers":12,"sex":19,"minAge":58,"maxAge":310,"enrollmentInfo":311,"targetDuration":313,"studyType":25,"phases":4,"briefSummary":314,"conditions":315,"keywords":319,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":321,"lastUpdatePostDateStruct":322,"startDateStruct":324,"completionDateStruct":326,"leadSponsor":328,"locationsCount":80},"100464991","sex-differential-host-microbiome-cvd-risk---a-longitudinal-cohort-approach-100464991","NCT05334888","Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach","Sex Hormone-specific Cardiovascular Risks in the Gut Microbiome-host Axis - A Longitudinal Cohort Study.","XCVD","Inclusion Criteria:\n\n* Age 18-50\n* Language requirements: German, English\n* Previous gender hormone replacement therapy (HRT).\n* Ability to give consent and written consent to participate.\n* Health insurance (for clarification of incidental findings)\n\nExclusion Criteria:\n\n* Diseases or functional disorders that, in the opinion of the study physician, preclude participation in the study.\n* Incapacity or other circumstances that do not allow study participants to fully understand the nature, significance and scope of this study.","50 Years",{"count":312,"type":24},200,"2 Years","The XCVD study investigates the influence of sex hormones on the composition of the gut microbiome and the possible emergence of cardiovascular risk factors. It will follow 200 healthy transgender individuals for five years during their hormone replacement therapy (HRT) and analyze them for the possible emergence of cardiovascular risk factors in relation to changes in the gut microbiome, metabolome, and immunome. We would also like to phenotype cardiovascular disease.",[316,30,317,318],"Transgender","Immune System","Cardiovascular Risk Factors",[320],"Transgender Medicine","2026-06-12",{"date":323,"type":42},"2026-06-15",{"date":325,"type":42},"2022-08-29",{"date":327,"type":24},"2030-12-31",{"name":329,"class":49},"Charite University, Berlin, Germany",{"id":331,"slug":332,"hasResults":12,"nctId":333,"briefTitle":334,"officialTitle":334,"acronym":4,"eligibilityCriteria":335,"healthyVolunteers":12,"sex":180,"minAge":336,"maxAge":337,"enrollmentInfo":338,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":340,"conditions":341,"keywords":345,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":351,"lastUpdatePostDateStruct":352,"startDateStruct":354,"completionDateStruct":356,"leadSponsor":358,"locationsCount":80},"100638771","agewise-unravelling-the-gut-hormone-axis-in-womens-ageing-100638771","NCT07614542","AGEWISE: Unravelling the Gut-Hormone Axis in Women's Ageing","Inclusion Criteria:\n\n* Female sex\n* Aged 40 to 64 years\n* Resident in mainland Portugal or the islands\n* Able and willing to provide written informed consent\n* Willing to provide stool and blood samples and complete three questionnaires\n\nExclusion Criteria:\n\n* Age below 40 years or 65 years and older\n* Inability to give informed consent\n* Refusal to provide stool or blood samples or complete questionnaires\n* Pregnancy\n* Diagnosed gastrointestinal disorders (including inflammatory bowel disease, Crohn's disease, ulcerative colitis, irritable bowel syndrome, chronic diarrhoea of unknown cause, or recurrent Clostridioides difficile infection)\n* Active oncological disease","40 Years","64 Years",{"count":339,"type":24},300,"AGEWISE is an observational study that aims to understand how changes in gut microbiome are related to hormonal changes during women's ageing, particularly across the different stages of menopause. The study will include healthy women aged 40 to 64 years living in Portugal, who will provide stool and blood samples and complete questionnaires about their health, lifestyle, diet, and menopausal symptoms. Researchers will study the gut microbiome together with hormone levels and markers of inflammation to better understand how menopause affects long-term health and to support the development of improved prevention strategies for women.",[189,30,342,343,344],"Hormonal Changes","Chronic Low-Grade Inflammation","Inflammaging",[346,347,348,349,350],"microbiome","biomarkers","metagenomics","menopausal transition","women's health","2026-05-22",{"date":353,"type":42},"2026-05-29",{"date":355,"type":42},"2025-06-02",{"date":357,"type":24},"2036-12",{"name":359,"class":49},"Gulbenkian Institute for Molecular Medicine",{"id":361,"slug":362,"hasResults":12,"nctId":363,"briefTitle":364,"officialTitle":365,"acronym":366,"eligibilityCriteria":367,"healthyVolunteers":18,"sex":19,"minAge":368,"maxAge":369,"enrollmentInfo":370,"targetDuration":4,"studyType":62,"phases":372,"briefSummary":373,"conditions":374,"keywords":379,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":383,"lastUpdatePostDateStruct":384,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":80},"100616740","mediterranean-diet-uptake-and-nutrition-on-child-health-inflammation-and-early-life-symbiosis-munchies-study-100616740","NCT07309536","Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES) Study","Mediterranean Diet Uptake and Nutrition on Child Health, Inflammation, and Early-life Symbiosis (MUNCHIES): A Randomized Controlled Trial","MUNCHIES","Inclusion Criteria:\n\n* Parent is ≥19 years of age.\n* Carried a singleton pregnancy.\n* Delivered at term (≥37 weeks gestation).\n* Delivered vaginally or by cesarean section.\n* Infant was born with a birth weight between 2,500 g and 4,500 g.\n* Toddler is between 24 and 36 months of age at enrollment.\n* Parent is able to communicate in English.\n* Parent is willing to adhere to the Mediterranean diet for their toddler for 3 weeks.\n* Parent is willing to participate in a nutrition education program for 3 months.\n* Parent is willing to complete all measurements and provide a stool sample from their toddler.\n\nExclusion Criteria:\n\n* Toddler has food allergies or dietary restrictions (e.g., gluten-free) that make it difficult to follow a Mediterranean diet.\n* Toddler is at high risk for food allergies (e.g., strong family history of multiple food allergies common to the Mediterranean diet).\n* Toddler is already following a Mediterranean diet.\n* Toddler has had recent or active consumption of antibiotics, probiotics, or prebiotic drops.\n* Toddler has an active acute illness, such as fever, diarrhea, or constipation.\n* Toddler was born with a congenital illness or malformation that could affect diet, inflammation, gut health, or body composition.\n* Toddler is currently breastfeeding, formula-feeding, or combination feeding.","24 Months","36 Months",{"count":371,"type":24},40,[64],"Toddlerhood (ages 2-3) is a critical window when the gut microbiome is still developing and eating habits are being established. Yet, many Canadian toddlers eat diets high in sugar and salt, which may affect long-term health. This study will test whether a MED diet can improve dietary inflammation, gut health, and body composition in toddlers and whether a tailored nutrition education program for parents can help families maintain healthy eating patterns.\n\nIn this study, toddlers will be randomly assigned to a 3-week MED diet or their usual diet. Families in the MED diet group will receive free meal boxes for the 3 weeks, plus guidance from a nutrition researcher through a structured education program. The standard diet group will continue their regular diet with general nutrition advice. Researchers will collect dietary information, body composition assessments, and stool samples to measure gut microbiome composition and metabolites.\n\nThis first study of a controlled diet intervention in toddlers, combining behavioral support, high-quality food provision, and advanced gut microbiome analysis, will help understand how early diet shapes lifelong eating habits and health, guiding public health strategies and precision nutrition approaches to prevent chronic disease from early life.",[30,375,376,377,378],"Body Composition","Adherence","Metabolites","Inflammation",[380,381,382,378],"Dietary patterns","Gastrointestinal microbiome","Body composition","2026-05-11",{"date":385,"type":42},"2026-05-12",{"date":387,"type":24},"2026-07-01",{"date":389,"type":24},"2027-11-01",{"name":276,"class":49},{"id":392,"slug":393,"hasResults":12,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":397,"eligibilityCriteria":398,"healthyVolunteers":12,"sex":19,"minAge":399,"maxAge":400,"enrollmentInfo":401,"targetDuration":4,"studyType":62,"phases":403,"briefSummary":404,"conditions":405,"keywords":410,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":430,"lastUpdatePostDateStruct":431,"startDateStruct":433,"completionDateStruct":435,"leadSponsor":437,"locationsCount":80},"100610251","goat-milk-derived-formula-vs-undiluted-goat-milk-in-infants-unable-to-exclusively-breastfeed-growth-and-biomarker-analysis-100610251","NCT07225153","Goat Milk-Derived Formula vs. Undiluted Goat Milk in Infants Unable to Exclusively Breastfeed: Growth and Biomarker Analysis","Goat Milk-Derived Formula Alternatives vs. Undiluted Goat Milk in Babies Unable to Exclusively Breastfeed: Analysis of Growth Metrics and Biological Markers","GMDFA","Inclusion Criteria:\n\n* • Infants aged = 08 -10 weeks with WAZ better than -1.8. (NIPS \\& ICF, 2019) Age Sex WAZ Weight in Kilograms 2 Month Boys WAZ\\>-1.8 4-5 kg 2 Month Girls WAZ\\>-1.8 4-5 kg Table 3: WAZ scores\n\n  * Living in Matiari District.\n  * Who has access to goat milk in their households.\n  * The Breastfeeding group: Women who exclusively breastfeeding and not giving and sort of formula or animal derived milk.\n  * Intervention Group: Women who do not breastfeed at all or give goat milk to their infants (2-3 feeds per day).\n  * No birth deformities\n\nExclusion Criteria:\n\n* • Infant birth weight \\\u003C WAZ -1.8 i.e. weight-for-age based on established growth standards, such as the World Health Organization (WHO).\n\n  * Birth deformities or disorders, such as genetic disorders, aerodigestive problems, or congenital anomalies.\n  * Plan to migrate during the next six months.\n  * We will exclude the women who exclusive breast feed and continue breast feeding for first 4 months.\n  * If the child is enrolled or included in any other interventional trial.\n  * Who does not have access to goat milk in their households.\n  * Are medically disqualified: Any potential participant who is deemed medically unfit for enrollment, due to the presence of severe or unstable health conditions that could compromise safety or interfere with the study outcomes, will be excluded from participation","8 Weeks","10 Weeks",{"count":402,"type":24},15,[64],"The goal of this clinical trial is to learn if Goat Milk-Derived Formula Alternatives (GMDFA) are safe and effective for infants who are unable to be exclusively breastfed. It will also study growth patterns, biological markers, and gut microbiome differences among infants receiving GMDFA, undiluted goat milk, or breast milk.\n\nThe main questions it aims to answer are:\n\n1. Do infants receiving GMDFA show similar growth patterns to those who are breastfed?\n2. Are biological markers of gut health and nutrition (such as calprotectin, lipocalin-2, CRP, and claudin) comparable between the groups?\n3. How do feeding types (GMDFA, goat milk, or breast milk) influence the infant gut microbiome composition, metabolic pathways, and lipid profiles?\n4. Is GMDFA a safe and nutritionally adequate feeding option for infants unable to be exclusively breastfed?\n\nWe will compare GMDFA, undiluted goat milk, and breast milk (reference group) to evaluate infant growth, gut health, and metabolic outcomes.\n\nParticipants will:\n\nBe randomly assigned to one of three feeding groups: GMDFA, undiluted goat milk, or breastfed\n\nAttend regular follow-up visits for growth measurements and sample collection (blood, stool, and breast milk where applicable)\n\nHave feeding practices monitored and recorded through caregiver interviews and feeding logs\n\nAdditional Analyses:\n\nMicrobiome analysis: to identify gut bacterial diversity and composition across feeding groups Metagenomic analysis: to explore functional genes and metabolic pathways related to nutrition and gut health Lipidomic analysis: to assess differences in lipid and fatty acid profiles in breast milk, goat milk, and infant samples",[406,407,408,30,409],"Malnutrition (Calorie)","Infant Nutrition Disorder","Growth Flatering","Lipidomics",[411,412,413,414,415,416,417,418,265,419,420,421,422,423,424,425,426,427,409,428,429],"Infant nutrition","goat milk","Infant feeding practices","Breastfeeding","Breastfeeding Alternatives","Alternate feeding practices","Growth outcomes","Infant growth metrics","Gut inflammation biomarkers","Calprotectin","Lipocalin-2","Claudin-2","C-reactive protein (CRP)","Randomized controlled trial","Rural Pakistan","Infant health","Malnutrition prevention","Breast milk","Metagenomics","2026-03-25",{"date":432,"type":42},"2026-03-30",{"date":434,"type":42},"2025-08-30",{"date":436,"type":24},"2026-03-18",{"name":438,"class":49},"Aga Khan University",{"id":440,"slug":441,"hasResults":12,"nctId":442,"briefTitle":443,"officialTitle":444,"acronym":4,"eligibilityCriteria":445,"healthyVolunteers":12,"sex":19,"minAge":181,"maxAge":59,"enrollmentInfo":446,"targetDuration":4,"studyType":62,"phases":447,"briefSummary":448,"conditions":449,"keywords":463,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":473,"lastUpdatePostDateStruct":474,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":80},"100572617","wild-blueberries-for-gut-brain-and-heart-health-in-adults-with-high-blood-pressure-100572617","NCT06735599","Wild Blueberries for Gut, Brain, and Heart Health in Adults With High Blood Pressure","Effects of Wild Blueberry Consumption on Gut, Brain, and Cardiovascular Health in Non-Hispanic Black and White Adults With High Blood Pressure","Inclusion Criteria:\n\n* Individuals 45-65 years of age\n* Diagnosis of elevated blood pressure or stage 1 hypertension (systolic blood pressure = 120-139 mmHg and\u002For diastolic blood pressure = 80-89 mmHg) for at least 6 months\n* BMI 25-35 kg\u002Fm2 via anthropometric measurements.\n* Ability to give consent\n\nExclusion Criteria:\n\n* Allergies to berries\n* Use of one hypertensive drug for less than three months\n* Use of more than one anti-hypertensive or statin drug, insulin, antibiotics, and anti-inflammatory drugs, active cancer, gastrointestinal, renal, cardiovascular, thyroid, and neurological disorders or severe head injury\n* Smoking\n* Alcohol consumption (\\>2 drinks\u002Fday)\n* Consuming antioxidant, probiotic, and prebiotic supplements\n* Pregnant or lactating\n* Participating in a weight loss program",{"count":371,"type":24},[64],"The purpose of the study is to determine the effectiveness of wild blueberries on cardiovascular health, cognitive function, and gut microbiota composition in non-Hispanic Black and White adults with elevated blood pressure.",[450,451,452,453,454,116,455,456,457,458,459,30,460,461,378,462],"Hypertension (Without Type 2 Diabetes Mellitus)","High Blood Pressure","Male","Female","Adult","Endothelial Function (Reactive Hyperemia)","Oxidative Stress","Diet","Overweight","Body Composition Measurement","Arterial Stiffness","Caucasian Whites","Microvascular Function",[464,465,458,451,466,467,468,469,470,471,472],"Blueberries","Hypertension","Endothelial Function","Cognitive Function","Dietary intervention","functional foods","gut microbiota","arterial stiffness","microvascular function","2026-03-23",{"date":475,"type":42},"2026-03-27",{"date":477,"type":42},"2024-09-17",{"date":479,"type":24},"2027-01-01",{"name":481,"class":49},"Georgia State University",{"id":483,"slug":484,"hasResults":12,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":12,"sex":19,"minAge":336,"maxAge":21,"enrollmentInfo":490,"targetDuration":4,"studyType":62,"phases":491,"briefSummary":492,"conditions":493,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":497,"lastUpdatePostDateStruct":498,"startDateStruct":499,"completionDateStruct":501,"leadSponsor":502,"locationsCount":80},"100532002","microbiome-and-diet-in-parkinsons-disease-100532002","NCT06207136","Microbiome and Diet in Parkinson's Disease","Canadian Parkinson's Microbiome Initiative: A Pilot Phase 2 Feasibility Randomized Controlled Trial of the MIND Diet in Parkinson's Disease","PD-Diet","Inclusion Criteria:\n\nEligible if the person living with Parkinson's has\u002Fis:\n\n1. a clinical diagnosis of PD,\n2. cognitively stable (no clinical dementia),\n3. between 40-80 years old,\n4. able to travel to UBC for 6 onsite visits over 18 months,\n5. sufficient English proficiency (coaching and cooking classes are in English only),\n6. on a stable dopaminergic medication for at least one month before baseline,\n7. computer and internet access at home, and can be available via video link for at least 80% of the study sessions.\n\nExclusion Criteria:\n\nNot eligible, if person has\u002Fis:\n\n1. a diagnosis of atypical parkinsonism,\n2. medical or psychiatric conditions that would prevent full participation in the nutrition intervention (such as food allergies), significant dysphagia, diabetes on insulin, anti-coagulation on warfarin, and inflammatory bowel disease,\n3. clinical dementia,\n4. unable to complete questionnaires or understand study instructions,\n5. using of immunomodulatory agents,\n6. used Probiotics in the last 4 weeks prior to study start,\n7. used Antibiotics in the last 3 months prior to study start,\n8. contraindications for MRI.",{"count":371,"type":24},[64],"The goal of this pilot study is to examine the feasibility and effects of an 18-month intervention diet compared to an active control diet (standard diet) in those living with Parkinson's Disease (PD), without dementia.\n\nResearch has shown that eating components of Mediterranean diets are associated with a 30% lower risk to develop PD and a 40% lower mortality rate in those living with PD. Diet may influence the gut and microbiomes, thus may affect PD risk and progression.\n\nThis study will examine how easy it will be to adhere to a certain type of diet for 18 months and what changes may occur in the gut microbiome and in PD symptoms on a specific diet during that time.\n\nThe study will involve in-person study visits at UBC as well as online diet coaching sessions and online group cooking classes over Zoom.\n\nThis is a randomized study, meaning that participants will be assigned by chance to either the Mediterranean-style diet group or the standard diet group for the duration of the 18 months.\n\nThis pilot study will also examine recruitment rates and retention, in order to prepare for a larger future study.",[494,495,30,496],"Parkinson Disease","Diet, Healthy","Gastrointestinal Microbiome","2026-03-19",{"date":473,"type":42},{"date":500,"type":42},"2024-12-03",{"date":299,"type":24},{"name":503,"class":49},"University of British Columbia",{"id":505,"slug":506,"hasResults":12,"nctId":507,"briefTitle":508,"officialTitle":509,"acronym":510,"eligibilityCriteria":511,"healthyVolunteers":18,"sex":512,"minAge":58,"maxAge":181,"enrollmentInfo":513,"targetDuration":4,"studyType":62,"phases":515,"briefSummary":516,"conditions":517,"keywords":532,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":547,"lastUpdatePostDateStruct":548,"startDateStruct":549,"completionDateStruct":551,"leadSponsor":553,"locationsCount":80},"100629969","impact-of-training-load-on-the-gut-microbiome-and-its-relation-to-exercise-performance-muscle-phenotype-and-markers-of-overreaching-in-healthy-men-100629969","NCT07481578","Impact of Training Load on the Gut miCrobiome And Its Relation to exeRcise Performance, mUscle Phenotype, and markerS of Overreaching in Healthy Men","ICARUS: Impact of Training Load on the Gut Microbiome and Its Relation to Exercise Performance, Muscle Phenotype, and Markers of Overreaching in Healthy Men: Phase A - Human Trial","ICARUS","Inclusion criteria:\n\n* Males between 18 and 45 years old.\n* Recreationally active individuals, with a weekly exercise training volume between one and six hours per week.\n* Good health status confirmed by a sport medical screening, which includes a sport medical questionnaire and resting electrocardiogram.\n* Body Mass Index (BMI) between 18.5 and 27.5 kg\u002Fm².\n* Masters the Dutch language.\n\nExclusion criteria:\n\n* Engagement in strenuous competitive sports one month prior to or during the study intervention.\n* Medication and vaccination: Pro- or antibiotic treatment during the past three months, non-steroidal anti-inflammatory drugs (NSAIDs) or cholestyramine during the past month, drugs interfering with intestinal permeability (e.g., prokinetics, laxatives, lubiprostone, loperamide, anti-spasmodics, linaclotide, proton pump inhibitors) during the past month. Vaccinations within one month prior to or during the study intervention.\n* Blood donations within three months or plasma donation within one month prior to or during the study intervention.\n* Inflammatory bowel disease (Crohn or colitis ulcerosa) or celiac disease.\n* Diagnosed irritable bowel syndrome.\n* Intake of any performance-enhancing medication or nutritional supplements known to modulate the gut microbiome in the two months prior to or during the study.\n* Substance abuse, including alcohol consumption of more than three units\u002Fday (weekly average).\n* Any injury or pathology considered a contraindication for performing physical exercise, as determined by the medical doctor overseeing the preparticipation medical screening.\n* No access to smartphone and\u002For computer with internet access.\n* No willingness to use the Polar Flow app and MijnEetmeter to collect physical activity, heart rate, sleep, and food intake data.\n* Concomitant participation in another interventional trial, without approval from the research team.\n* Any other reasons considered by the research team that the participant will not complete the study.","MALE",{"count":514,"type":24},45,[64],"The goal of this study is to learn how different amounts of supervised indoor cycling training change gut health (gut bacteria, the substances gut bacteria make, and the gut barrier integrity), and how these changes relate to changes in fitness, muscle health, and signs of doing too much training (a state called 'overreaching'). The study includes healthy, recreationally active men aged 18 to 45 years.\n\nThe primary questions, for which the study is powered (sufficient participants included), are:\n\n1. Does moderate load training change blood and faecal levels of butyrate (a short-chain fatty acid made by gut bacteria) after eight weeks compared with a control group?\n2. Compared to moderate load training, do higher training loads lead to different responses in blood and faecal levels of butyrate?\n\nResearchers will compare:\n\n* A control group that does not complete structured training;\n* A moderate-load training group that completes eight weeks of supervised cycling (4x\u002Fweek);\n* A high-load training group that completes four weeks of moderate-load training followed by four weeks of higher training load (twice the number of training sessions).\n\nParticipants will:\n\n* Be randomly assigned to one of the three groups;\n* Complete 8 weeks of supervised indoor cycling sessions if assigned to a training group;\n* Complete four study assessment periods (baseline, after week four, after week eight, and after a short taper (rest period);\n* Provide blood, stool, skeletal muscle, urine, saliva, and breath samples during the assessment periods;\n* Complete fitness and performance tests and questionnaires during the assessment periods.",[518,519,520,30,521,522,523,524,525,526,527,528,529,530,531],"Exercise","Overreaching","Butyrate","Exercise Performance","Skeletal Muscle","Glucose Tolerance","Hormones","Vascular Health","Muscle Adaptation","Physical Fitness","Heart Rate Variability (HRV)","Anthropometric Measurements","Metabolic Health","Food Intake",[533,534,535,536,537,538,539,540,519,541,542,543,528,544,545,546],"Exercise training","Training load","Overload training","Fecal butyrate","Gut health","Exercise performance","Muscle phenotype","Physical fitness","Glucometabolic health","Vascular health","Muscle adaptation","Anthropometrics","Metabolic health","Food intake","2026-03-16",{"date":497,"type":42},{"date":550,"type":42},"2024-10-07",{"date":552,"type":24},"2027-05-31",{"name":554,"class":49},"Stefan De Smet",{"id":556,"slug":557,"hasResults":12,"nctId":558,"briefTitle":559,"officialTitle":560,"acronym":4,"eligibilityCriteria":561,"healthyVolunteers":18,"sex":19,"minAge":181,"maxAge":562,"enrollmentInfo":563,"targetDuration":4,"studyType":62,"phases":565,"briefSummary":566,"conditions":567,"keywords":570,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":574,"lastUpdatePostDateStruct":575,"startDateStruct":577,"completionDateStruct":579,"leadSponsor":580,"locationsCount":80},"100628672","effect-of-prebiotics-in-saudi-adults-with-type-2-diabetes-100628672","NCT07464691","Effect of Prebiotics in Saudi Adults With Type 2 Diabetes","Effect of Prebiotics in Saudi Adults With Type 2 Diabetes: Randomized Control Trail","Inclusion Criteria:\n\n* Saudi, both males and females.\n* Aged between 45-60 years old\n* BMI between 25 - 30 kg\u002Fm2\n* No antibiotic use for the last six months\n\nCases:\n\n* Type 2 diabetes.\n* Duration of diabetes ≥ 5 years\n* HbA1c ≥ 6.5-8.0\n\nControls: (subjects with normal OGTT results)\n\n* Fasting plasma glucose (FPG) \\\u003C 100 mg\u002Fdl (5.6mmol\u002Fl)\n* A1C less than 5.7%\n* 2-hour post-load glucose \\\u003C 140 mg\u002Fdl (7.8 mmol\u002Fl)\n\nExclusion Criteria:\n\n1. Patients with Type 1 diabetes.\n2. Pregnant \\& breastfeeding females.\n3. Any serious disease such as renal or hepatic disease, thyroid functions, coeliac disease, or the presence of gastroparesis.\n4. Use of weight-loss treatments within 3 months before inclusion\n5. Diabetic patients on acarbose, metformin (\\> 1 g\u002Fday), and GLP-1 medications.\n6. Use of antibiotic drugs for the last 3 months of treatments that influence gut microbiota composition.\n7. Bypass surgery, Laparoscopic Sleeve Gastrectomy (LSG), or colon restriction.\n8. Chronic gastrointestinal disorder (except irritable bowel syndrome).\n9. Patients with a history or symptoms of obstruction or Inflammatory bowel disease\n10. Atypical diets (such as vegetarians, vegans, and heavy consumption of dietary supplements).\n11. Use of pre\u002Fprobiotics or fiber supplements within 3 months before inclusion.\n12. Any drug that can interfere with food absorption or gut flora, such as chronic consumption of loperamide, cholestyramine, antacids, H2-receptor blockers, proton pump inhibitors, fibrates, corticosteroids, or sex steroids, omega-3 unsaturated fatty acids acid, or anti-inflammatory drugs.\n13. Autonomic neuropathy\n14. Any immune-compromised disease.\n15. Daily alcohol consumption \\> 30 g.\n16. Involvement in another clinical trial in the past 6 months.\n17. Any legal incompetence or mental inability to provide consent.","60 Years",{"count":564,"type":24},100,[64],"This study will explore how a natural food ingredient called oligofructose affects blood glucose levels, lipid profiles, inflammation biomarkers, and gut bacteria in Saudi adults with type 2 diabetes. Oligofructose is a type of dietary fiber found in foods such as onions, garlic, and bananas. It is known to help the growth of \"good\" bacteria in the intestine, which may improve digestion and metabolism.\n\nA total of 100 adults (50 with type 2 diabetes and 50 without diabetes) will take part in this research. Participants will be randomly assigned to receive either oligofructose or a placebo twice daily for 12 weeks. Blood tests will be done at the beginning and at weeks 4, 8, and 12 to check changes in blood glucose, lipid profiles, and inflammation.\n\nThe goal of this study is to find out whether adding oligofructose to the diet can help people with diabetes improve their blood glucose control, reduce inflammation, and support a healthier balance of gut bacteria.",[568,530,378,30,569],"Type 2 Diabetes","Obesity",[571,572,30,573],"Prebiotics","Dietary supplement","Oligofructose","2026-03-09",{"date":576,"type":42},"2026-03-11",{"date":578,"type":24},"2026-09-13",{"date":299,"type":24},{"name":581,"class":49},"Princess Nourah Bint Abdulrahman University",{"id":583,"slug":584,"hasResults":12,"nctId":585,"briefTitle":586,"officialTitle":587,"acronym":4,"eligibilityCriteria":588,"healthyVolunteers":18,"sex":19,"minAge":589,"maxAge":590,"enrollmentInfo":591,"targetDuration":4,"studyType":62,"phases":592,"briefSummary":593,"conditions":594,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":598,"lastUpdatePostDateStruct":599,"startDateStruct":601,"completionDateStruct":603,"leadSponsor":605,"locationsCount":80},"100618581","flourish-exploring-the-early-infant-gut-microbiome-100618581","NCT07333482","Flourish: Exploring the Early Infant Gut Microbiome","Flourish Study: A Randomized, Three-Arm Longitudinal Clinical Study of Microbiome-Guided Interventions in Cesarean-Born Infants","Inclusion Criteria:\n\n* Infants are qualified for this study if they are 0 to 3 months of age at time of enrollment.\n* Infants must have been delivered via Cesarean delivery (C-section), either scheduled or emergent.\n* Infants must have been at least 36 weeks gestation at time of delivery.\n* Infants and their caregivers must reside in the United States with a US mailing address.\n\nExclusion Criteria:\n\n* Infants can not have been given probiotic supplements in their life at recruitment. This includes probiotic powder or supplements or formula with probiotic addition or multivitamin with probiotic addition.\n* Twin and multiple birth infants are not accepted in this study.\n* Infants cannot have the following existing health conditions:\n* Gastrointestinal conditions: Hirschsprung disease, eosinophilic gastrointestinal disorders (EGID) including eosinophilic esophagitis (EoE), necrotizing enterocolitis (NEC), short bowel syndrome (SBS)\n* Immune or auto-immune conditions: Severe Combined Immunodeficiency (SCID), human immunodeficiency virus (HIV)), excluding eczema and rashes\n* Congenital conditions: cleft lip or cleft palate, congenital heart disease, cerebral palsy, fragile X syndrome, down syndrome, spina bifida, cystic fibrosis, phenylketonuria (PKU), congenital hypothyroidism (CHT), galactosaemia)\n* Blood disorders (sickle cell disease, thalassemia, hemophilia)\n* Infant or any immediate family member has previously received results from an at-home microbiome stool test (excluding standard clinical diagnostic testing such as stool culture or pathogen testing)","0 Months","3 Months",{"count":23,"type":24},[64],"The goal of this clinical trial is to learn whether microbiome analysis, education, and personalized recommendations can improve gut health and reduce early markers of immune-related conditions in infants aged 0-3 months delivered via Cesarean section. The study aims to determine whether these interventions can increase beneficial bacteria, decrease C-section-associated microbiome signatures, reduce opportunistic pathogens, and improve functional potential for HMO digestion and SCFA production. The study also seeks to assess whether improvements in microbiome composition are associated with a reduced prevalence of early atopic symptoms.\n\nResearchers will compare three groups: a full intervention arm that receives microbiome reports, coaching, personalized recommendations, and educational materials; a limited intervention arm that receives simplified reports and basic recommendations; and a control arm that receives no results until study completion. This design allows evaluation of both a comprehensive intervention and a more scalable, minimal-results model.\n\nParticipants will:\n\n1. Provide six microbiome stool samples over a 24-month period.\n2. Provide additional small stool samples at two timepoints for exploratory metabolomic analysis.\n3. Receive microbiome reports and guidance according to their assigned study arm.\n4. Complete surveys on infant health history, symptoms, diet, and environmental exposures.\n5. Participate in standardized eczema assessment(s) administered by a Nurse Practitioner and evaluated by a Pediatric Allergy Specialist if any symptoms are reported.\n\nThis study seeks to demonstrate that targeted microbiome support can positively shift gut microbial development in C-section infants and may reduce risks linked to the early stages of the atopic march. Findings may inform scalable strategies for delivering microbiome-based support in early life and improve long-term health outcomes for this high-risk population.",[595,30,596,597],"Microbiota","Eczema","Microbiome","2026-02-20",{"date":600,"type":42},"2026-02-24",{"date":602,"type":42},"2026-01-31",{"date":604,"type":24},"2028-09",{"name":606,"class":79},"Seeding Inc",{"id":608,"slug":609,"hasResults":12,"nctId":610,"briefTitle":611,"officialTitle":611,"acronym":4,"eligibilityCriteria":612,"healthyVolunteers":18,"sex":19,"minAge":58,"maxAge":310,"enrollmentInfo":613,"targetDuration":4,"studyType":62,"phases":614,"briefSummary":615,"conditions":616,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":620,"completionDateStruct":622,"leadSponsor":623,"locationsCount":80},"100577633","effects-of-mango-or-low-fat-cookie-consumption-on-gut-health-and-its-relationship-with-mental-sexual-and-skin-health-100577633","NCT06800833","Effects of Mango or Low-Fat Cookie Consumption on Gut Health, and Its Relationship With Mental, Sexual and Skin Health","Inclusion Criteria:\n\n* Generally healthy subjects\n* BMI 20-40 kg\u002Fm2\n\nExclusion Criteria:\n\n* Smoker\n* Pregnant woman\n* Required antibiotics use\n* Required dietary supplement use\n* Required medication of metabolic disorders, mental health and sexual health\n* Allergy to mango or wheat",{"count":252,"type":24},[64],"The objective of the proposed research is to determine the effects of fresh mango consumption on gut microbiome, and its relationship with skin health, sexual and mental health in relatively healthy adults.",[30],"2026-01-28",{"date":619,"type":42},"2026-01-30",{"date":621,"type":42},"2025-01-23",{"date":299,"type":24},{"name":624,"class":49},"San Diego State University",{"id":626,"slug":627,"hasResults":12,"nctId":628,"briefTitle":629,"officialTitle":629,"acronym":630,"eligibilityCriteria":631,"healthyVolunteers":12,"sex":19,"minAge":4,"maxAge":4,"enrollmentInfo":632,"targetDuration":634,"studyType":25,"phases":4,"briefSummary":635,"conditions":636,"keywords":639,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":642,"lastUpdatePostDateStruct":643,"startDateStruct":645,"completionDateStruct":647,"leadSponsor":649,"locationsCount":651},"100310782","fecal-microbiota-transplant-national-registry-100310782","NCT03325855","Fecal Microbiota Transplant National Registry","FMT","Inclusion Criteria:\n\n* Recipient Inclusion Criteria\n\n  * Ability to give informed consent\n  * Receiving FMT or other gut-related microbiota product within 90 days after providing consent\n  * Access to internet and\u002For telephone\n* Donor Inclusion\n\n  * Ability to give informed consent\n  * Providing stool sample for FMT\n\nExclusion Criteria:\n\n* Incarceration",{"count":633,"type":24},4000,"10 Years","A national data registry of patients receiving fecal microbiota transplantation (FMT) or other gut-related-microbiota products designed to prospectively assess short and long-term safety and effectiveness",[637,638,30],"Fecal Microbiota Transplantation","Clostridium Difficile Infection",[630,640,641],"CDI","Fecal Matter Transplant","2026-01-18",{"date":644,"type":42},"2026-01-21",{"date":646,"type":42},"2017-09-20",{"date":648,"type":24},"2027-08",{"name":650,"class":49},"American Gastroenterological Association",53,{"id":653,"slug":654,"hasResults":12,"nctId":655,"briefTitle":656,"officialTitle":657,"acronym":4,"eligibilityCriteria":658,"healthyVolunteers":18,"sex":19,"minAge":336,"maxAge":659,"enrollmentInfo":660,"targetDuration":4,"studyType":62,"phases":661,"briefSummary":663,"conditions":664,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":667,"lastUpdatePostDateStruct":668,"startDateStruct":670,"completionDateStruct":672,"leadSponsor":674,"locationsCount":80},"100498780","phase-1-curcumin-and-retinal-study-100498780","NCT05774704","Curcumin and Retinal Study","Curcumin and Retinal Amyloid-beta Pilot Study","Inclusion:\n\n* Both male and female, age 40 - 89 years.\n* Diagnosed with Aβ deposits in retina (peripheral superior quadrants)--to be confirmed after consent obtained. If there is documentation the potential participant has been diagnosed with Aβ deposits in retina within 6 months before the consent session, we will use this diagnosis\u002Fdocumentation for eligibility criteria. Otherwise, the ophthalmic exam will be repeated after consent is obtained for the study.\n* No pre-existing liver or kidney diseases by self-report.\n\nExclusion:\n\n* Patients with ocular diseases (macular degeneration, severe diabetes retinopathy)\n* Had used systemic antibiotics within 1 month prior to the start of the study intervention\n* Had taken any turmeric or curcumin products within 2 weeks prior to the start of the study intervention\n* Had a known allergy to black pepper\n* Women that are pregnant or breastfeeding","89 Years",{"count":252,"type":24},[185,662],"PHASE2","To test how two weeks of curcumin supplementation would cross the blood brain barrier (BBB) and attach to amyloid beta proteins, to assess the feasibility (safety and bioavailability), and to explore the resulting abundance\u002Fcomposition of gut microbiota.",[665,30,666],"Bioavailability","Safety","2026-01-12",{"date":669,"type":42},"2026-01-13",{"date":671,"type":42},"2023-08-21",{"date":673,"type":24},"2026-12-31",{"name":675,"class":49},"Texas Tech University Health Sciences Center",{"id":677,"slug":678,"hasResults":12,"nctId":679,"briefTitle":680,"officialTitle":680,"acronym":4,"eligibilityCriteria":681,"healthyVolunteers":12,"sex":19,"minAge":58,"maxAge":682,"enrollmentInfo":683,"targetDuration":4,"studyType":25,"phases":4,"briefSummary":685,"conditions":686,"keywords":688,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":693,"lastUpdatePostDateStruct":694,"startDateStruct":696,"completionDateStruct":698,"leadSponsor":700,"locationsCount":80},"100490758","impact-of-gut-microbiome-on-metabolic-and-bowel-function-during-the-first-year-after-spinal-cord-injury-100490758","NCT05670288","Impact of Gut Microbiome on Metabolic and Bowel Function During the First Year After Spinal Cord Injury","Inclusion Criteria:\n\n1. 18-85 years of age\n2. diagnosis of traumatic SCI at the cervical to lumbar level (C3-L2)\n3. classification of A, B, C (motor complete, incomplete).\n\nExclusion Criteria:\n\n1. Women who are pregnant prior to consent\n2. neurological impairment other than SCI\n3. self-reported history of Crohn's disease or diverticulitis\n4. irritable bowel syndrome\n5. gastric blockage\u002Fobstruction or swallowing disorder\n6. prior GI surgery\n7. intrathecal pump\n8. concurrent usage of functional electrical stimulation for bowel management (e.g., constipation).\n9. able to ambulate","85 Years",{"count":684,"type":24},35,"The Investigators will recruit 35 participants with acute SCI (within 6 weeks of injury) Fasting blood collection and bowel function survey will be conducted 3 times: at baseline \\[within 6 weeks of injury\\], 6, and 12 months after SCI. Stool will be collected for gut microbiome analysis 3 times.",[687,30],"Spinal Cord Injuries",[689,378,690,691,692],"SCI","Bowel Function","Blood Sugar","Lipid Profiles","2025-12-10",{"date":695,"type":42},"2025-12-17",{"date":697,"type":42},"2023-10-15",{"date":699,"type":24},"2027-02-28",{"name":701,"class":49},"University of Alabama at Birmingham",{"id":703,"slug":704,"hasResults":12,"nctId":705,"briefTitle":706,"officialTitle":706,"acronym":707,"eligibilityCriteria":708,"healthyVolunteers":18,"sex":512,"minAge":58,"maxAge":109,"enrollmentInfo":709,"targetDuration":4,"studyType":62,"phases":710,"briefSummary":712,"conditions":713,"keywords":716,"overallStatus":232,"whyStopped":4,"lastUpdateSubmitDate":724,"lastUpdatePostDateStruct":725,"startDateStruct":727,"completionDateStruct":729,"leadSponsor":731,"locationsCount":80},"100615646","early-phase-1-effect-of-antifungals-on-the-intestinal-microbiome---a-randomized-controlled-proof-of-concept-trial-100615646","NCT07295314","Effect of Antifungals on the Intestinal Microbiome - a Randomized, Controlled, Proof-of-concept Trial","FAME","Inclusion Criteria:\n\n* Male, 18-35 years of age at the time of signing informed consent\n* Healthy, as determined by medical history and physical examination; minor clinical abnormalities allowed if not introducing additional risk or interfering with study procedures\n* Capable of giving written informed consent and able to comply with study requirements\n* Normal defecation pattern (≤3 times\u002Fday and ≥3 times\u002Fweek)\n\nExclusion Criteria:\n\n* Major illness in the past 3 months, or significant chronic medical illness deemed unfavorable for enrollment\n* Past or current gastrointestinal disease that may influence the gut microbiota (including inflammatory bowel disease or medication-treated irritable bowel syndrome)\n* History of immunodeficiency\n* History of malignancy\n* Alcohol intake \\>3 units\u002Fday on average\n* Known allergy to antifungal drugs\n* Use of antibiotics (except topical) within the past 3 months\n* Use of antifungals (except topical) within the past 3 months\n* Planned prolonged travel (\\>4 weeks) to tropical countries during the study period\n* Receipt of an investigational product within 3 months prior to study day 0\n* Use of prescription or non-prescription drugs, herbal or dietary supplements within 3 months (unless deemed safe by investigator)\n* Difficulty with blood donation or poor venous access in either arm\n* Donation of \\>500 mL of blood in the past 3 months\n* Any other condition or circumstance that, in the investigator's opinion, could be harmful to the subject or compromise data interpretation",{"count":61,"type":24},[711],"EARLY_PHASE1","The goal of this clinical trial is to learn how the antifungal drug fluconazole affects the gut microbiome and immune system in healthy volunteers.\n\nThe main questions it aims to answer are:\n\n* Does fluconazole change the gut bacteriome and mycobiome composition after 14 days of treatment?\n* How long do these changes last (4 weeks and 6 months after treatment)?\n* Does fluconazole affect the body's immune responses, such as blood cell activity and antifungal antibodies?\n\nResearchers will compare two groups: participants who take fluconazole for 14 days and participants who receive no intervention.\n\nParticipants will:\n\n* Either take one fluconazole tablet (200 mg) daily for 14 days, or receive no treatment\n* Provide stool samples and blood samples at several timepoints\n* Return for follow-up visits up to 6 months after treatment\n\nThis study is conducted at Amsterdam UMC, location AMC, with a planned enrollment of 50 healthy male volunteers aged 18-35 years.",[30,714,715],"Healthy Adult Male","Antifungal Therapy",[717,718,719,720,721,722,723],"Fluconazole","Antifungal Drugs","Mycobiome","Bacteriome","Microbiota Diversity","Innate Immune Response","Healthy Volunteers","2025-12-08",{"date":726,"type":42},"2025-12-19",{"date":728,"type":24},"2026-01",{"date":730,"type":24},"2027-12",{"name":732,"class":49},"Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)",{"id":734,"slug":735,"hasResults":12,"nctId":736,"briefTitle":737,"officialTitle":738,"acronym":739,"eligibilityCriteria":740,"healthyVolunteers":12,"sex":19,"minAge":58,"maxAge":741,"enrollmentInfo":742,"targetDuration":4,"studyType":62,"phases":744,"briefSummary":745,"conditions":746,"keywords":754,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":759,"lastUpdatePostDateStruct":760,"startDateStruct":762,"completionDateStruct":764,"leadSponsor":765,"locationsCount":80},"100599273","feasibility-and-potential-efficacy-of-herbs-and-spices-for-improving-dietary-quality-in-college-students-a-pilot-study-100599273","NCT07082348","Feasibility and Potential Efficacy of Herbs and Spices for Improving Dietary Quality in College Students: A Pilot Study","Assessing the Feasibility and Potential Efficacy of Herbs and Spices for Improving Dietary Quality and Adherence to the Dietary Guidelines for Americans in College Students With Poor Dietary Quality: A Pilot Study","HerbSpicesDiet","Inclusion Criteria:\n\n* College students (undergraduate and graduate)\n* Ages 18-39 years\n* BMI 18.5-40 kg\u002Fm\n* Having poor dietary quality (a Rapid Prime Diet Quality Score of 12 or below),\n* Maintain current lifestyle habits (e.g., medications\u002F supplement use, exercise, and sleep), and avoid taking new supplements or medications throughout the study.\n\nExclusion Criteria:\n\n* Individuals diagnosed with myocardial infarction within the past 6 months\n* Uncontrolled hypertension\n* BMIs \\\u003C18.5 or \\>40 kg\u002Fm2\n* Autoimmune disease or immune compromised\n* A recent diagnosis of cancer or under current treatment for cancer\n* A history of kidney stones\n* Having pacemaker\n* Participating in a weight loss program\n* Having a history of any significant GI disease\n* Insulin use\n* Currently on dialysis\n* Currently consuming pro-\u002Fpre-biotics or antiobiotics\n* Diagnosed with unstable chronic metabolic disease\n* Have allergies to any herbs and spices\n* Are pregnant\u002Fnursing\n* Participating in another investigational study\n* Unable or unwilling to give consent","39 Years",{"count":743,"type":24},30,[64],"The goal of this single-arm feasibility, pilot study is to assess the feasibility, acceptability, and potential effectiveness of the Herbs and Spices Nutrition Education Program (HSNP-focusing on incorporating herbs and spices into the diet for adherence to the DGA's) for determining the scalability of implementing this intervention for a larger scale, more comprehensive study The main questions it aims to answer are:\n\n* What is the feasibility and acceptability of incorporating herbs and spices into the diet along with DGA-focused nutrition education through the HSNP in college students with poor dietary quality?\n* What are the preliminary effects of the HSNP on dietary intake\u002Fquality, cardiometabolic, and gut health in college students with poor dietary quality?\n* What are the barriers associated with HSNP implementation in college students with poor dietary quality?\n\nParticipants will:\n\n* Be asked to come to the study site initially for a Screening Study Visit to confirm eligibility.\n* Be asked to come the clinical study site for a Pre-HSNP and Post-HSNP Study Visit (one week prior starting the HSNP and after week 6 of completing the HSNP) for assessments of cardiometabolic and gut health.\n* Be asked to come to the Nutrition Center for weeks 0 and 3 of the HSNP, where they will receive education on the Dietary Guidelines for Americans and the health benefits of herbs and spices, have a sensory evaluation of foods, be provided budget-friendly recipes and resources, and given take-home herbs, spices, and supporting materials\n* Be asked to complete 3-Day Food Records throughout the 6 week study period for assessment of dietary quality (4 total)",[747,748,749,750,30,692,751,752,753,375,544],"Dietary Quality","Feasibility Studies","College Student","Dietary Guidelines for Americans","Herbs and Spices","Acceptability","Inflammation Biomarkers",[755,756,757,758,192],"dietary quality","dietary guidelines for americans","college students","cardiometabolic health","2025-11-18",{"date":761,"type":42},"2025-11-24",{"date":763,"type":42},"2025-07-03",{"date":673,"type":24},{"name":766,"class":49},"University of Nevada, Las Vegas"]