[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584891":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":35,"centralContacts":48,"locations":58,"responsibleParty":180,"collaborators":183,"id":199,"slug":200,"hasResults":201,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":205,"eligibilityCriteria":206,"healthyVolunteers":201,"sex":207,"minAge":208,"maxAge":209,"enrollmentInfo":210,"targetDuration":35,"studyType":213,"phases":214,"briefSummary":216,"conditions":217,"keywords":219,"overallStatus":105,"whyStopped":35,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":228,"completionDateStruct":230,"leadSponsor":232,"locationsCount":233},{"fullName":5,"class":6},"All India Institute of Medical Sciences","OTHER",[8,15,21,26],{"label":9,"type":10,"description":11,"interventionNames":12},"Sham transplantation with sham diet","SHAM_COMPARATOR","1. Oral placebo 1 BD for 3 days before first FMT\n2. Sham transplantation with instillation of clean water at 0, 2, and 6 weeks followed by (if treatment responder) - 8-weekly during maintenance between 10 to 42 weeks\n3. Sham diet for 48 weeks 4. 5-ASA for 48 weeks",[13,14],"Other: Sham transplantation","Other: Sham diet",{"label":16,"type":17,"description":18,"interventionNames":19},"Fecal Microbiota Transplant(FMT) and Sham diet","EXPERIMENTAL","1. Oral vancomycin 500 mg BD for 3 days before the first FMT.\n2. FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 42 weeks\n3. Sham diet for 48 weeks 4. 5-ASA for 48 weeks",[20,14],"Other: Fecal Microbial Transplantation",{"label":22,"type":17,"description":23,"interventionNames":24},"Anti-inflammatory diet and sham transplantation","1. Oral placebo 1 BD for 3 days before first FMT\n2. Sham transplantation (clean water) via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 42 weeks\n3. Anti-inflammatory diet for 48 weeks 4. 5-ASA for 48 weeks",[13,25],"Other: Anti inflammatory diet",{"label":27,"type":17,"description":28,"interventionNames":29},"Fecal Microbiota Transplant(FMT) and Anti inflammatory diet","1. Oral vancomycin 500 mg BD for 3 days before the first FMT.\n2. FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 42 weeks\n3. Anti-inflammatory diet for 48 weeks\n4. 5-ASA for 48 weeks",[25,20],[31,36,40,44],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Sham transplantation","Sham FMT will involve saline infusion via colonoscopy",[22,9],null,{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Anti inflammatory diet","The modified diet plan will be given to each study participant",[22,27],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Fecal Microbial Transplantation","This will involve colonoscopic instillation of fecal transplant",[27,16],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"Sham diet","Dietary counselling alone",[16,9],[49,54],{"name":50,"role":51,"phone":52,"phoneExt":35,"email":53},"Prof Vineet Ahuja, DM Gastroenterology","CONTACT","+91-9810707170","vineet.aiims@gmail.com",{"name":55,"role":51,"phone":56,"phoneExt":35,"email":57},"Dr Himanshu Narang, DM Gastroenterology","+91-8800316504","h92narang@gmail.com",[59,87,103,126,148,164],{"facility":60,"status":61,"city":62,"state":63,"zip":35,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":71,"contacts":72},"Department of Gastroenterology, Lisie Hospital","NOT_YET_RECRUITING","Kochi","Kerala","India","IN",{"type":67,"coordinates":68},"Point",[69,70],76.26022,9.93988,{"lat":70,"lon":69},[73,77,81,84],{"name":74,"role":51,"phone":75,"phoneExt":35,"email":76},"Dr Mathew Philip, DM Gasteroentrology","+91-9846045469","drmathewphilip@gmail.com",{"name":78,"role":51,"phone":79,"phoneExt":35,"email":80},"Dr Kiran Josy, DM Gastroentrology","+91-9745243939","drkiranjosy@gmail.com",{"name":82,"role":83,"phone":35,"phoneExt":35,"email":35},"Dr Mathew Philip, DM Gastroenterology","PRINCIPAL_INVESTIGATOR",{"name":85,"role":86,"phone":35,"phoneExt":35,"email":35},"Dr Kiran Josy, DM Gastroenterology","SUB_INVESTIGATOR",{"facility":88,"status":61,"city":89,"state":90,"zip":35,"country":64,"countryCode":65,"cosmosGeoPoint":91,"geoPoint":95,"contacts":96},"Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion","Mumbai","Maharashtra",{"type":67,"coordinates":92},[93,94],72.88261,19.07283,{"lat":94,"lon":93},[97,101],{"name":98,"role":51,"phone":99,"phoneExt":35,"email":100},"Dr Sanjay Chandnani, DM Gasteroentrology","+91-9049708800","sanjy.med@gmail.com",{"name":102,"role":83,"phone":35,"phoneExt":35,"email":35},"Dr Sanjay Chandnani, DM Gastroenterology",{"facility":104,"status":105,"city":106,"state":107,"zip":108,"country":64,"countryCode":65,"cosmosGeoPoint":109,"geoPoint":113,"contacts":114},"Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences","RECRUITING","New Delhi","National Capital Territory of Delhi","110029",{"type":67,"coordinates":110},[111,112],77.2148,28.62137,{"lat":112,"lon":111},[115,117,119,120,122,124],{"name":116,"role":51,"phone":52,"phoneExt":35,"email":53},"Prof Vineet Ahuja, DM Gasteroentrology",{"name":118,"role":51,"phone":56,"phoneExt":35,"email":57},"Dr Himanshu Narang, DM Gastroentrology",{"name":50,"role":83,"phone":35,"phoneExt":35,"email":35},{"name":121,"role":86,"phone":35,"phoneExt":35,"email":35},"Prof Govind Makharia, DM Gastroenterology",{"name":123,"role":86,"phone":35,"phoneExt":35,"email":35},"Dr Purva Mathur, MD Microbiology",{"name":125,"role":86,"phone":35,"phoneExt":35,"email":35},"Dr Prasenjit Das, MD Pathology",{"facility":127,"status":61,"city":128,"state":129,"zip":35,"country":64,"countryCode":65,"cosmosGeoPoint":130,"geoPoint":134,"contacts":135},"Department of Gastroenterology, Dayanand Medical College","Ludhiana","Punjab",{"type":67,"coordinates":131},[132,133],75.85379,30.91204,{"lat":133,"lon":132},[136,140,144,146],{"name":137,"role":51,"phone":138,"phoneExt":35,"email":139},"Prof Ajit Sood, DM Gasteroentrology","+91-9815400718","ajitsood10@gmail.com",{"name":141,"role":51,"phone":142,"phoneExt":35,"email":143},"Dr Arshdeep Singh, DM Gastroentrology","+91-9815337764","drarshdeepsingh@gmail.com",{"name":145,"role":83,"phone":35,"phoneExt":35,"email":35},"Prof Ajit Sood, DM Gastroenterology",{"name":147,"role":86,"phone":35,"phoneExt":35,"email":35},"Dr Arshdeep Singh, DM Gastroenterology",{"facility":149,"status":61,"city":150,"state":151,"zip":35,"country":64,"countryCode":65,"cosmosGeoPoint":152,"geoPoint":156,"contacts":157},"Department of Gastroentrology, Postgraduate Institute of Medical Education and Research","Chandigarh","Punjab\u002FHaryana",{"type":67,"coordinates":153},[154,155],76.7884,30.73629,{"lat":155,"lon":154},[158,162],{"name":159,"role":51,"phone":160,"phoneExt":35,"email":161},"Dr Vishal Sharma, DM Gasteroentrology","+91-8872813399","docvishalsharma@gmail.com",{"name":163,"role":83,"phone":35,"phoneExt":35,"email":35},"Dr Vishal Sharma, DM Gastroenterology",{"facility":165,"status":61,"city":166,"state":167,"zip":35,"country":64,"countryCode":65,"cosmosGeoPoint":168,"geoPoint":172,"contacts":173},"Department of Gastroenterology, Institute of Medical Sciences, Banaras Hindu University","Varanasi","Uttar Pradesh",{"type":67,"coordinates":169},[170,171],83.01041,25.31668,{"lat":171,"lon":170},[174,178],{"name":175,"role":51,"phone":176,"phoneExt":35,"email":177},"Dr Devesh Prakash Yadav, DM Gasteroentrology","+91-8130856563","devesh.thedoc@gmail.com",{"name":179,"role":83,"phone":35,"phoneExt":35,"email":35},"Dr Devesh Prakash Yadav, DM Gastroenterology",{"type":83,"investigatorFullName":181,"investigatorTitle":182,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Prof. Vineet Ahuja","Professor",[184,186,188,190,192,194,197],{"name":185,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh",{"name":187,"class":6},"Institute of Medical Sciences of the Banaras Hindu University, India",{"name":189,"class":6},"Dayanand Medical College and Hospital",{"name":191,"class":6},"Indraprastha Institute of Information Technology Delhi",{"name":193,"class":6},"Lisie Hospital",{"name":195,"class":196},"Indian Council of Medical Research","OTHER_GOV",{"name":198,"class":6},"Lokmanya Tilak Municipal Medical College and Hospital","100584891","a-study-to-evaluate-the-effect-of-fecal-transplant-and-dietary-changes-on-disease-activity-in-patients-with-newly-diagnosed-active-ulcerative-colitis-100584891",false,"NCT06895252","A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Ulcerative Colitis","Efficacy of Microbiome Manipulation Strategies (fecAL Microbial Transplantation OR Anti-inflammatory diEt OR Both) in Combination With 5-aminosalicylic Acid for Induction and Maintenance of Remission in Patients With Mild to Moderate tReatment Naive Active Ulcerative Colitis: a Multicentre Double-blind Factorial Randomized Controlled Trial(ALTER-UC)","ALTER-UC","Inclusion Criteria:\n\n1. Patients with treatment-naive ulcerative colitis of any disease extent. Patients with proctitis will be limited to 25% of the entire pool of patients.\n2. Mild to moderate endoscopically active disease (modified Mayo clinic score (mMS) 3-6, with Mayo endoscopic score greater than or equal to 2).\n3. Aged between 18-75 years.\n4. Patients giving consent for FMT.\n5. Patients who agree to adhere to the diet schedule.\n6. Patients on oral or topical ASA for less than 4 weeks.\n7. Patients on oral steroids\u002F topical steroids for less than 1 week.\n8. Infective colitis should be ruled out by histologic appearance of crypt architecture distortion\u002Fbasal plasmacytosis, or two sigmoidoscopies, at least 7 days apart showing evidence of endoscopic activity.\n\nExclusion Criteria:\n\n1. Patients with severe disease (mMS equal to 7-9)\n2. Clinical signs of fulminant colitis or toxic megacolon\n3. Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns Disease.\n4. Patients who have been initiated on other therapies (biologicals or immunosuppressants (azathioprine\u002F 6-mercaptoprine\u002Fmethotrexate)) for greater than 2 weeks\n5. Patients requiring hospitalization\n6. Pregnant or lactating women\n7. Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease.\n8. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#\n9. Patients infected with human immunodeficiency virus (HIV) # 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.","ALL","18 Years","75 Years",{"count":211,"type":212},220,"ESTIMATED","INTERVENTIONAL",[215],"NA","Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon and rectum, characterized by mucosal inflammation and symptomslike diarrhea, abdominal pain, and rectal bleeding. It is a subtype of inflammatory bowel disease (IBD) and results from a combination of genetic predisposition, environmental factors, and immune dysregulation. UC is associated with significant gut microbiota dysbiosis, marked by reduced beneficial bacteria and increased harmful taxa. With rising prevalence in developing countries like India, effective and accessible treatments remain a critical need. This multi-center randomized factorial double blind placebo controlled treat through trial will utilize a 2x 2 factorial design to randomize patients of mild to moderate (modified Mayo score 3-6) endoscopically active (Mayo endoscopic score: \\>1) treatment naÃive UC in 1:1:1:1 ratio to fecal microbiota transplantation (FMT) + anti-inflammatory diet (AID) +5-aminisalicylic acid (5-ASA) (Intervention, Group A) vs fecal microbiota transplantation + sham diet +5-aminisalicylic acid(Intervention, Group B) vs sham transplantation + anti-inflammatory diet +5-aminisalicylic acid(Intervention, Group C) vs sham transplantation\n\n\\+ sham diet +5-aminisalicylic acid(Control, Group D). In the induction phase patients will receive FMT\u002Fsham transplantation at 0, 2 and 6 weeks along with AID\u002FSham diet and 5-ASA for 10 weeks. Outcome will be assessed at 10 weeks, Treatment failure will be out of trial. Patients with clinical response at 10 weeks will continue in the maintenance phase and will receive FMT\u002Fsham transplantation at 10, 18, 26, 34, and 42 weeks along with AID\u002FSham diet and 5-ASA till48 weeks. Outcome will be assessed at 48 weeks. Treatment failure will be out of trial. The primary efficacy outcome will evaluate fecal microbial transplantation or anti- inflammatory diet or combination of both vs placebo. The primary outcomes are proportion of patients having clinical remission and endoscopic response at week 10 and proportion of patients having clinical remission and endoscopic remission at week 48. Modified intention to treat analysis will be done and patients who receive at least 1 dose of intervention will be included for outcome assessment.",[218],"Ulcerative Colitis (UC)",[220,221,222,37,223],"factorial design","Randomized controlled trial","Fecal microbiota transplantation","Ulcerative colitis","2025-04-01",{"date":226,"type":227},"2025-04-04","ACTUAL",{"date":229,"type":227},"2025-03-15",{"date":231,"type":212},"2028-03-15",{"name":5,"class":6},6]