[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585751":3},{"organization":4,"armGroups":7,"interventions":31,"overallOfficials":53,"centralContacts":58,"locations":67,"responsibleParty":181,"collaborators":36,"id":184,"slug":185,"hasResults":186,"nctId":187,"briefTitle":188,"officialTitle":189,"acronym":190,"eligibilityCriteria":191,"healthyVolunteers":186,"sex":192,"minAge":193,"maxAge":194,"enrollmentInfo":195,"targetDuration":36,"studyType":198,"phases":199,"briefSummary":201,"conditions":202,"keywords":204,"overallStatus":109,"whyStopped":36,"lastUpdateSubmitDate":210,"lastUpdatePostDateStruct":211,"startDateStruct":214,"completionDateStruct":216,"leadSponsor":218,"locationsCount":219},{"fullName":5,"class":6},"All India Institute of Medical Sciences","OTHER",[8,16,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Fecal Microbiota Transplantation and Anti inflammatory diet and advanced therapy","EXPERIMENTAL","1.Oral vancomycin 500 mg BD for 3 days before the first FMT 2.FMT via colonoscopy at 0, 2, and 6 weeks for induction of remission 3.FMT via colonoscopy every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4.If the patient is a non-responder or has treatment failure to induction, he\u002Fshe will be withdrawn from the study. 5.Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6.AID for 48 weeks. 7.Advanced therapy as standard dose and schedule",[13,14,15],"Other: Fecal Microbial Transplantation","Other: Anti-Inflammatory Diet","Other: Advanced Therapy",{"label":17,"type":10,"description":18,"interventionNames":19},"Fecal Microbiota Transplantation and sham diet\u002Fstandard dietary counselling and advanced therapy","1.Oral vancomycin 500 mg BD for 3 days before the first FMT 2.FMT via colonoscopy at 0, 2, and 6 weeks for induction of remission 3.FMT via colonoscopy every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4.If the patient is a non-responder or has treatment failure to induction, he\u002Fshe will be withdrawn from the study. 5.Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6. Sham AID\u002FStandard dietary counseling for 48 weeks. 7. Advanced therapy as standard dose and schedule",[13,20,15],"Other: Sham Diet",{"label":22,"type":10,"description":23,"interventionNames":24},"Sham Transplantation and Anti inflammatory diet and advanced therapy","1.Oral placebo 1 BD for 3 days before first FMT 2.Sham FMT via colonoscopy (instillation of clean water) at 0, 2, and 6 weeks 3.Sham FMT via colonoscopy (instillation of clean water) every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4.If the patient is a non-responder or has treatment failure to induction therapy, he\u002Fshe will be withdrawn from the study. 5.Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6. AID for 48 weeks. 7. Advanced therapy as standard dose and schedule.",[14,25,15],"Other: Sham transplantation",{"label":27,"type":28,"description":29,"interventionNames":30},"Sham transplantation and Sham Diet and advanced therapy","SHAM_COMPARATOR","1.Oral placebo 1 BD for 3 days before first FMT 2. Sham FMT via colonoscopy (instillation of clean water) at 0, 2, and 6 weeks 3. Sham FMT via colonoscopy (instillation of clean water) every 8 weeks (week 10, 18, 26, 34, 42) for maintenance of remission, if the patient is responder to the induction therapy 4. If the patient is a non-responder or has treatment failure to induction therapy, he\u002Fshe will be withdrawn from the study. 5. Patients with secondary loss of response, in the maintenance phase, will be withdrawn from the study 6. Sham AID\u002FStandard dietary counseling for 48 weeks 7. Advanced therapy as standard dose and schedule",[25,20,15],[32,37,41,45,49],{"type":6,"name":33,"description":34,"armGroupLabels":35,"otherNames":36},"Fecal Microbial Transplantation","This will involve colonoscopic instillation of fecal transplant",[9,17],null,{"type":6,"name":38,"description":39,"armGroupLabels":40,"otherNames":36},"Anti-Inflammatory Diet","The modified diet plan will be given to each study participant",[9,22],{"type":6,"name":42,"description":43,"armGroupLabels":44,"otherNames":36},"Sham transplantation","Sham FMT will involve saline infusion via colonoscopy",[22,27],{"type":6,"name":46,"description":47,"armGroupLabels":48,"otherNames":36},"Sham Diet","Dietary counselling alone",[17,27],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":36},"Advanced Therapy","Advanced therapy as standard dose and schedule",[9,17,22,27],[54],{"name":55,"affiliation":56,"role":57},"Prof Vineet Ahuja, DM Gastroenterology","Department of Gastroenterology, AIIMS, New Delhi","PRINCIPAL_INVESTIGATOR",[59,63],{"name":55,"role":60,"phone":61,"phoneExt":36,"email":62},"CONTACT","+91-9810707170","vineet.aiims@gmail.com",{"name":64,"role":60,"phone":65,"phoneExt":36,"email":66},"Dr Himanshu Narang, DM Gasteroentrology","+91-8800316504","h92narang@gmail.com",[68,92,107,130,151,166],{"facility":69,"status":70,"city":71,"state":72,"zip":36,"country":73,"countryCode":74,"cosmosGeoPoint":75,"geoPoint":80,"contacts":81},"Department of Gastroenterology, Lisie Hospital","NOT_YET_RECRUITING","Kochi","Kerala","India","IN",{"type":76,"coordinates":77},"Point",[78,79],76.26022,9.93988,{"lat":79,"lon":78},[82,85,89,90],{"name":83,"role":60,"phone":84,"phoneExt":36,"email":36},"Dr Mathew Philip, DM Gastroenterology","+91-9846045469",{"name":86,"role":60,"phone":87,"phoneExt":36,"email":88},"Dr Kiran Josy, DM Gastroenterology","+91-9745243939","drkiranjosy@gmail.com",{"name":83,"role":57,"phone":36,"phoneExt":36,"email":36},{"name":86,"role":91,"phone":36,"phoneExt":36,"email":36},"SUB_INVESTIGATOR",{"facility":93,"status":70,"city":94,"state":95,"zip":36,"country":73,"countryCode":74,"cosmosGeoPoint":96,"geoPoint":100,"contacts":101},"Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion","Mumbai","Maharashtra",{"type":76,"coordinates":97},[98,99],72.88261,19.07283,{"lat":99,"lon":98},[102,106],{"name":103,"role":60,"phone":104,"phoneExt":36,"email":105},"Dr Sanjay Chandnani, DM Gastroenterology","+91-9049708800","sanjy.med@gmail.com",{"name":103,"role":57,"phone":36,"phoneExt":36,"email":36},{"facility":108,"status":109,"city":110,"state":111,"zip":112,"country":73,"countryCode":74,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences","RECRUITING","New Delhi","National Capital Territory of Delhi","VINEET AHUJA",{"type":76,"coordinates":114},[115,116],77.2148,28.62137,{"lat":116,"lon":115},[119,121,123,124,126,128],{"name":120,"role":60,"phone":61,"phoneExt":36,"email":62},"Prof Vineet Ahuja, DM Gasteroentrology",{"name":122,"role":60,"phone":65,"phoneExt":36,"email":66},"Dr Himanshu Narang, DM Gastroentrology",{"name":55,"role":57,"phone":36,"phoneExt":36,"email":36},{"name":125,"role":91,"phone":36,"phoneExt":36,"email":36},"Prof Govind Makharia, DM Gastroenterology",{"name":127,"role":91,"phone":36,"phoneExt":36,"email":36},"Dr Purva Mathur, MD Microbiology",{"name":129,"role":91,"phone":36,"phoneExt":36,"email":36},"Dr Prasenjit Das, MD Pathology",{"facility":131,"status":70,"city":132,"state":133,"zip":134,"country":73,"countryCode":74,"cosmosGeoPoint":135,"geoPoint":139,"contacts":140},"Department of Gastroenterology, Dayanand Medical College","Ludhiana","Punjab","DR AJIT SOOD",{"type":76,"coordinates":136},[137,138],75.85379,30.91204,{"lat":138,"lon":137},[141,145,149,150],{"name":142,"role":60,"phone":143,"phoneExt":36,"email":144},"Prof Ajit Sood, DM Gastroenterology","+91-9815400718","ajitsood10@gmail.com",{"name":146,"role":60,"phone":147,"phoneExt":36,"email":148},"Dr Arshdeep Singh, DM Gastroenterology","+91-9815337764","drarshdeepsingh@gmail.com",{"name":142,"role":57,"phone":36,"phoneExt":36,"email":36},{"name":146,"role":91,"phone":36,"phoneExt":36,"email":36},{"facility":152,"status":70,"city":153,"state":154,"zip":36,"country":73,"countryCode":74,"cosmosGeoPoint":155,"geoPoint":159,"contacts":160},"Department of Gastroentrology, Postgraduate Institute of Medical Education and Research,","Chandigarh","Punjab\u002FHaryana",{"type":76,"coordinates":156},[157,158],76.7884,30.73629,{"lat":158,"lon":157},[161,165],{"name":162,"role":60,"phone":163,"phoneExt":36,"email":164},"Dr Vishal Sharma, DM Gastroenterology","+91-8872813399","docvishalsharma@gmail.com",{"name":162,"role":57,"phone":36,"phoneExt":36,"email":36},{"facility":167,"status":70,"city":168,"state":169,"zip":36,"country":73,"countryCode":74,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Department of Gastroenterology, Institute of Medical Sciences","Varanasi","Uttar Pradesh",{"type":76,"coordinates":171},[172,173],83.01041,25.31668,{"lat":173,"lon":172},[176,180],{"name":177,"role":60,"phone":178,"phoneExt":36,"email":179},"Dr Devesh Prakash Yadav, DM Gastroenterology","+91-8130856563","devesh.thedoc@gmail.com",{"name":177,"role":57,"phone":36,"phoneExt":36,"email":36},{"type":57,"investigatorFullName":182,"investigatorTitle":183,"investigatorAffiliation":5,"oldNameTitle":36,"oldOrganization":36},"Prof. Vineet Ahuja","Professor","100585751","a-study-to-evaluate-the-effect-of-fecal-transplant-and-dietary-changes-on-disease-activity-in-patients-with-ulcerative-colitis-on-advanced-therapies-100585751",false,"NCT06906445","A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Ulcerative Colitis on Advanced Therapies","Efficacy of Microbiome Manipulation Strategies Fecal Microbial Transplant or Anti-inflammatory Diet or Both With Advanced Therapies BiOlOgics and Small Molecules to Break the Therapeutic Ceiling in Active Ulcerative Colitis BOOST-UC A Multicenter Double Blind Factorial Randomized Controlled Trial","BOOST-UC","Inclusion Criteria:\n\n1. Adult (age 18 to 75 years) patients\n2. Patients with active UC (defined as mMS equal or greater than 3 with rectal bleed score equal or greater than 1 and Endoscopic Mayo score equal or greater than 2 documented within 3 months of randomization or mild symptoms with high inflammatory burden or poor prognostic features).\n3. Any disease extent E1, E2 or E3. Patients with Proctitis will be limited to 25 percent of the entire pool of patients.\n4. Patients with an inadequate response, loss of response, or intolerance to conventional therapies example, aminosalicylates, corticosteroids, immunosuppressants or advanced therapies including but not limited to anti TNF alpha agents, anti-integrins, anti IL 12 or IL 23 agents, anti IL 23 agents, JAK inhibitors, or S1P receptor modulators. The last administration of any such treatment must have occurred at least five half-lives prior to randomization.\n5. Confirmed diagnosis of UC. The diagnosis must be confirmed by endoscopic and histologic evidence and corroborated by a histopathology report\n6. Subjects who are willing and able to comply with treatment plan, laboratory tests, daily bowel movement diary call and other study procedures\n7. Subjects who are willing to provide a written informed consent for FMT\n8. Agree to adhere to the diet schedule\n9. Infective colitis ruled out Biopsy showing crypt architecture distortion or basal plasmacytosis, OR two sigmoidoscopies, at least 7 days apart showing evidence of endoscopic activity\n\nExclusion Criteria:\n\n1. Hospitalization of exacerbation of UC requiring intravenous corticosteroids\n2. Patients already on biologics (anti-tumor necrosis factor inhibitors) or small molecules (tofacitinib) for equal or more than 2 weeks.\n3. Clinical signs of fulminant colitis or toxic megacolon\n4. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin or CMV (histology or IHC and or tissue PCR) at screening. (The patients with positive assay will be treated appropriately and tests will be repeated. Those with negative assay and persistent activity will be included in the study.)\n5. Active or inadequately treated infections, including Mycobacterium tuberculosis.\n6. Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's Disease.\n7. Patients infected with human immunodeficiency virus (HIV)\n8. Patients with current or past history of malignancy.\n9. Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, Hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.\n10. Pregnant females","ALL","18 Years","75 Years",{"count":196,"type":197},220,"ESTIMATED","INTERVENTIONAL",[200],"NA","Ulcerative colitis (UC) is a chronic inflammatory disease of the colon characterized by superficial mucosal inflammation. Treatment aims to achieve and maintain remission, improve quality of life, and minimize complications. Advanced therapies, including biologics and small molecules, have significantly improved UC management by targeting specific inflammatory pathways. However, due to the multifactorial nature of UC-driven by genetic, environmental, and microbial factors-many patients do not achieve sustained remission, highlighting a therapeutic ceiling. Gut microbial dysbiosis and immune dysregulation are central to UC pathogenesis, with diet playing a critical role in influencing the gut microbiome. While biologics and small molecules have limitations, innovative approaches like combining fecal microbiota transplantation (FMT) and dietary interventions with advanced therapies show promise. FMT restores microbial balance, modulates immunity, and reduces inflammation, while dietary modifications, such as anti-inflammatory diets, enhance FMT efficacy by creating a favorable environment for donor microbiota engraftment. The present study is designed to evaluate the efficacy of three different microbiome manipulation strategies- FMT, AID and FMT + AID in combination with advanced therapies in patients with active UC in a 2X2 factorial trial design. Patients would be randomized into four different arms: FMT, AID, FMT+AID and placebo. The advanced therapies (biologics or small molecules) would be given in all four arms as standard therapy. With this design the trial would answer two important questions: a) efficacy of combination treatment with advanced therapies and microbiome manipulation strategies in active UC, and b) comparative efficacy of different microbiome manipulation strategies.",[203],"Ulcerative Colitis",[205,33,206,207,208,209],"Randomized Controlled Trial","Anti-inflammatory diet","Factorial design","Ulcerative colitis","Advanced therapy","2025-03-31",{"date":212,"type":213},"2025-04-02","ACTUAL",{"date":215,"type":213},"2025-03-15",{"date":217,"type":197},"2028-03-15",{"name":5,"class":6},6]