[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611300":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":21,"centralContacts":28,"locations":37,"responsibleParty":59,"collaborators":20,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":68,"eligibilityCriteria":69,"healthyVolunteers":64,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":20,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":85,"whyStopped":20,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Stanford University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention arm (MITI-001)","EXPERIMENTAL","Dosed with MITI-001",[13],"Drug: MITI-001 administration",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DRUG","MITI-001 administration","A complex gut bacterial community (MITI-001) will be given endoscopically and orally",[9],null,[22,25],{"name":23,"affiliation":5,"role":24},"Michael Fischbach, PhD","STUDY_DIRECTOR",{"name":26,"affiliation":5,"role":27},"Sean P Spencer, MD, PhD","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":20,"email":33},"Sean Assistant Professor of Medicine","CONTACT","6507365555","seanspen@stanford.edu",{"name":35,"role":31,"phone":20,"phoneExt":20,"email":36},"Clinical Research Coordinator","aadiao@stanford.edu",[38,51],{"facility":39,"status":20,"city":40,"state":41,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":20},"Stanford Digestive Health Clinic","Redwood City","California","94063","United States","US",{"type":46,"coordinates":47},"Point",[48,49],-122.23635,37.48522,{"lat":49,"lon":48},{"facility":5,"status":20,"city":52,"state":41,"zip":53,"country":43,"countryCode":44,"cosmosGeoPoint":54,"geoPoint":58,"contacts":20},"Stanford","94305",{"type":46,"coordinates":55},[56,57],-122.16608,37.42411,{"lat":57,"lon":56},{"type":27,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":20,"oldOrganization":20},"Sean Spencer","Assistant Professor of Medicine","100611300","early-phase-1-use-of-a-complex-gut-bacterial-consortium-miti-001-for-the-treatment-of-irritable-bowel-syndrome-with-diarrhea-100611300",false,"NCT07238790","Use of A Complex Gut Bacterial Consortium (MITI 001) for the Treatment of Irritable Bowel Syndrome With Diarrhea","A Phase 1 Study to Evaluate the Safety of a Complex Gut Bacterial Consortium (MITI 001) for the Treatment of Irritable Bowel Syndrome With Diarrhea","CURE-IBS-D","Inclusion Criteria:\n\n1. Age 18 to 65 years inclusive at the time of signing the informed consent.\n2. Diagnosis of IBS-D according to the Rome IV criteria (Lacy 2017).\n3. At least 1 of the following measures of microbiome dysfunction:\n\n   1. Primary bile acid proportion ≥ 12% in stool samples, or\n   2. Positive hydrogen breath test (with either glucose or lactulose substrate) (Rezaie 2017)\n4. Normal C-reactive protein level\n5. Gallbladder intact\n6. Willing to use appropriate contraception during the treatment period and for one week after the last study visit.\n\n   * Male participants with partners who are women of childbearing potential (WOCBP): Appropriate contraception includes condoms or other means considered adequate by the responsible Investigator.\n   * Female participants who are WOCBP: Appropriate contraception includes condoms, an intrauterine device, hormonal contraception, or other means considered adequate by the responsible Investigator.\n7. Capable of giving signed informed consent as described in Appendix 1, which includes compliance with the requirements and restrictions listed in the informed consent form and in this protocol.\n8. Able to tolerate the planned course of antibiotics, EGD, and colonoscopy with bowel lavage.\n\nExclusion Criteria:\n\n1. Inflammatory bowel disease\n2. Untreated enteric infections\n3. History of gastrointestinal (GI) surgery: All participants with GI surgeries below the pylorus will be excluded from this study. This includes participants with a history of colectomy, segmental colonic resection, and small bowel resections.\n4. Documented severe gastroparesis\n5. Active intestinal obstruction\n6. Dysphagia (oropharyngeal, esophageal, functional, or neuromuscular)\n7. History of recurrent aspiration episodes\n8. Any conditions associated with a high risk of bleeding, including but not limited to coagulopathy\u002Fbleeding disorder, severe liver disease, active or recent GI bleeding, or recent abdominal or other GI surgery\n9. Active diagnosis of major depressive disorder\n10. Severe immunodeficiency, inherited or acquired (e.g., human immunodeficiency virus, active chemotherapy or immunosuppressive medications \\[including steroids, biologic therapy, or bone marrow suppressive agent\\], or radiation therapy)\n11. Any other significant medical condition that could confound or interfere with evaluation of safety or tolerability or prevent compliance with the study protocol at the discretion of the Investigator\n12. Active antibiotic use (except protocol-specified antibiotics)\n13. Active treatment with high levels of immunosuppressive therapies (active chemotherapy or immunosuppressive medications \\[including steroids, biologic therapies, or bone marrow suppressive agents\\], or radiation therapy)\n14. Active anticoagulant or antiplatelet therapy, or use of other medications associated with a high risk of bleeding within 48 hours prior to endoscopy on Day 1\n15. Use of a probiotic within one month prior to dosing of MITI-001 on Day 1\n16. Simultaneous participation in another interventional clinical trial\n17. Renal insufficiency (estimated glomerular filtration rate \\\u003C 50 mL\u002Fmin)\n18. Absolute neutrophil count \\\u003C 1000 μL, platelet count \\\u003C 50 × 109\u002FL, or hemoglobin level \\\u003C 6.5 g\u002FdL\n19. Pregnant, breastfeeding, or planning pregnancy during the study period\n20. Active drug or alcohol use disorder\n21. Known allergy or anaphylaxis to vancomycin, metronidazole, ciprofloxacin, or polyethylene glycol\n22. Inability to comply with research requirements","ALL","18 Years","65 Years",{"count":74,"type":75},13,"ESTIMATED","INTERVENTIONAL",[78],"EARLY_PHASE1","While the pathophysiology of diarrhea-predominant irritable bowel syndrome (IBS-D) is complex and heterogeneous, dysbiosis of the gut microbiome is frequently observed, suggesting that a substantial subset of patients with irritable bowel syndrome (IBS) have symptoms that are initiated and\u002For perpetuated by a microbiome dysfunction. Successful randomized controlled trials (RCT) for IBS-D (Ford 2018; Black 2022) leveraging microbiome-targeted therapies (antibiotics or low microbiome fermentation diets) suggest the gut microbiome is at least partially involved in IBS symptoms. Furthermore, fecal microbiota transplantation (FMT) for patients with IBS-D has demonstrated promising results (El-Salhy 2020), supporting the possibility that altering the microbiome composition could ameliorate IBS-D symptoms.\n\nMITI-001 is a transplantable gut bacterial community composed of 157 live bacterial strains, encompassing 79 genera of commensal bacteria, that have been isolated from healthy donor stool, purified, and banked. The hypothesis of the proposed research is that MITI-001 can target the pathophysiologic lesion in a subset of IBS-D patients, restore the altered microbial metabolic process, and thus alleviate IBS-D symptoms.",[81,82],"IBS (Irritable Bowel Syndrome)","Diarrhea",[84],"IBS with Diarrhea Predominance (IBS-D)","NOT_YET_RECRUITING","2025-11-16",{"date":88,"type":89},"2025-11-20","ACTUAL",{"date":91,"type":75},"2025-12",{"date":93,"type":75},"2030-12",{"name":5,"class":6},2]