[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microbiome-composition\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microbiome-composition":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,42],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":30,"lastUpdatePostDateStruct":31,"startDateStruct":34,"completionDateStruct":36,"leadSponsor":38,"locationsCount":41},"100626752","the-effects-of-an-oral-nutritional-intervention-on-the-small-intestine-microbiome-100626752",false,"NCT07439718","The Effects of an Oral Nutritional Intervention on the Small Intestine Microbiome","Inclusion Criteria:\n\n1. Males or females aged 18 to 60 years, inclusive, at enrollment.\n2. BMI of ≥18.5 but \\\u003C30 kg\u002Fm2.\n3. Healthy, as determined based on self-reported medical history.\n4. No planned change in diet or medical interventions during the study.\n5. Willing to collect fecal samples and retrieve sampling capsules from feces.\n6. Able to understand and to sign a written informed consent prior to study enrollment.\n7. Willing and able to comply with the requirements for participation in this study.\n\nExclusion Criteria:\n\n1. Prior or suspected gastrointestinal disease (as reported by the participant) which, in the investigator\u002Fstudy doctor's opinion, would lead to fistula formation, intestinal stricturing, or obstruction leading to a risk of capsule non-excretion (i.e. achalasia, active ulcer disease, eosinophilic esophagitis, Crohn's disease, ulcerates colitis, celiac disease, irritable bowel syndrome, stenosis of the GI tract).\n2. Any prior gastrointestinal surgery (as reported by the participant) which, in the investigator\u002Fstudy doctor's opinion, would lead to intestinal stricturing or obstruction leading to a risk of capsule non-excretion (i.e. previous esophageal, gastric, small intestinal, or colonic surgery). Note: appendectomy, cholecystectomy, hysterectomy, oophorectomy, hemorrhoid surgery more than 3 months prior to enrollment are acceptable.\n3. History of chronic diarrhea (defined as Bristol stool scale 5 to 7; or persistent or recurrent loose or watery stools lasting for more than 4 weeks), as reported by the participant.\n4. History of chronic constipation (defined as having less than 3 bowel movements per week) in the past month, as reported by the participant.\n5. Any history of obstructive symptoms in the previous 3 months prior to enrollment, as reported by the participant.\n6. Diagnosis of any organic motility disorder, including gastroparesis, intestinal pseudo-obstruction, systemic sclerosis, Ogilvie's syndrome, as reported by the participant.\n7. Diagnosis of any malabsorption disorder (i.e. malabsorption syndrome, lactose malabsorption), as reported by the participant.\n8. History of oropharyngeal dysphagia or other swallowing disorder with a risk of aspiration of the capsule, as reported by the participant.\n9. Any concurrent cancer diagnosis, as reported by the participant.\n10. Any cancer treatment within the past year, as reported by the participant.\n11. History of known abdominal or pelvic radiation treatment at any time in the past, as reported by the participant.\n12. Any cardiovascular, endocrine, renal, liver, or other chronic disease likely to affect motility (i.e. diabetes mellitus, concurrent biliary tract stones, kidney stones, etc.), as reported by the participant.\n13. Antibacterial\u002Fantifungal therapy in the past 3 months prior to enrolment, as reported by the participant.\n14. Use of any medications or supplements that could substantially alter gastrointestinal acidity, motor function, or microbiota (e.g. proton pump inhibitors, H2 receptor antagonists, opioids, prokinetics, anticholinergics, laxatives) in the past 4 weeks prior to enrollment, as reported by the participant.\n15. Underwent colon cleanse or bowel preparation in the 2 weeks prior to enrollment, as reported by the participant.\n16. Scheduled for an MRI at any time during the study duration. Potential participants may be eligible to participate once their MRI procedure is completed.\n17. Females of childbearing age who are pregnant or lactating, as reported by the participant (should an X-ray be required for confirmation of capsule passage; a urine pregnancy test will be administered beforehand).\n18. Alcohol intake higher than 2 servings per day over a week (for males), or more than 1 serving per day over a week (for females), as reported by the participant. A serving is 0.3 dl of strong alcohol, 1 dl of wine, or 3 dl of beer.\n19. Currently participating in another interventional study.\n20. Family or hierarchical relationships with the research team members.",true,"ALL","18 Years","60 Years",{"count":20,"type":21},25,"ESTIMATED","INTERVENTIONAL",[24],"NA","This is a single-center, single-arm study, aiming at enrolling 25 healthy adult participants to evaluate chronic effects of oil. Specifically, we aim to assess the impact on gut microbiome after a one-month intervention with oil.",[27,28],"Microbiome Composition","Microbiome","RECRUITING","2026-04-21",{"date":32,"type":33},"2026-04-22","ACTUAL",{"date":35,"type":33},"2026-02-23",{"date":37,"type":21},"2026-05-31",{"name":39,"class":40},"Société des Produits Nestlé (SPN)","INDUSTRY",1,{"id":43,"slug":44,"hasResults":11,"nctId":45,"briefTitle":46,"officialTitle":47,"acronym":48,"eligibilityCriteria":49,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":50,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":53,"briefSummary":54,"conditions":55,"keywords":59,"overallStatus":29,"whyStopped":4,"lastUpdateSubmitDate":62,"lastUpdatePostDateStruct":63,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":5},"100609750","aimmune-longitudinal-collaboration-study-100609750","NCT07218640","Aimmune Longitudinal Collaboration Study","Aimmune Therapeutics Manufacturing, LLC Longitudinal Collaboration Study: Evaluating the Impact of Lifestyle Factors on the Microbiome","FIBER-IMPACT","Inclusion Criteria:\n\n1. 18 years of age or greater\n2. Able to sign informed consent in English\n3. Households (2 or more adults) or individuals who are willing to provide a minimum of 3 separate stool samples per week and utilize a manual stool sampling tool. Alternatively, participants who can come to a collection site and leave stool samples a minimum of 3 days per week throughout the duration of the study.\n4. Are generally healthy\n5. Agreeable to adding chia seeds to diet\n6. Have access to a smartphone\n\nExclusion Criteria:\n\n1. Less than 18 years of age\n2. Greater than 50 years of age\n3. Unable to provide a minimum of 3 stool samples per week\n4. Active donors for a commercial product\n5. Anyone who previously made a lot of a finished product\n6. Diagnosed with a digestive, intestinal, or other condition that contraindicates consuming a daily serving size of chia seeds (\\~2.5 tbsp).","50 Years",{"count":52,"type":21},60,[24],"This study will include healthy households around the Irvine, CA area (based local to employees) and Tempe, AZ and Philadelphia, PA sites that will be instructed to take a daily fiber supplement (2.5 tablespoons of chia seeds \\[\\~10.3g of fiber\\] which is one serving) for two months. Participants will use a stool sampling tool to facilitate ease of stool collection, or they may donate at a study site. Half of participants will add chia seeds to their diet at the beginning of the study and then return to their baseline diet for the second half of the study; half of participants maintain their baseline diet for the first half of the study and add chia seeds to their diet at the second half of the study as a cross-over design. Households (or individual participants, if their household is not participating) will be chosen at random to decide who implements the intervention in the first half versus the second half of the study. Data measurement including metabolomics and sequencing of stool samples, blood sampling for biobanking, stool IgA analysis, stress and diet evaluations will occur initially and throughout the study. Lifestyle questionnaires including but not limited to diet surveys, stress, or depression screening may be collected through electronic forms or telephonically. During enrollment, participants may be asked to complete questionnaires focused on medical, family, dietary, and social histories.\n\nAt the end of the study, donor microbiota samples from individuals that are IgA low (undetectable) throughout the study will be evaluated from the presence of microbes that can degrade IgA. If investigators find this is the case, investigators will screen for microbes that can degrade IgA. For individuals that show persistent high fecal IgA or show a substantial improvement in IgA, investigators will transplant fecal samples or spores from fecal samples into germ-free mice to further understand the microbiome and pathophysiology relationship. For the latter, the investigator's hypothesis is that fiber exposure of a specific type will reprogram the microbiome to stimulate IgA broadly to the entire microbiome as occurs with pectin derivative treated mice. The investigator's goal will be to isolate the microbes that respond to fiber to alter levels of IgA in the gut lumen.",[56,27,57,58],"Stool Spore Colony Forming Units","Dietary Fiber","Stress",[60,61,58,28],"Spore Colony-Forming Units","Dietary fiber","2025-10-16",{"date":64,"type":33},"2025-10-20",{"date":66,"type":21},"2025-10",{"date":68,"type":21},"2026-07",{"name":70,"class":40},"Aimmune Therapeutics, Inc."]