[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584538":3},{"organization":4,"armGroups":7,"interventions":30,"overallOfficials":48,"centralContacts":53,"locations":62,"responsibleParty":182,"collaborators":185,"id":201,"slug":202,"hasResults":203,"nctId":204,"briefTitle":205,"officialTitle":206,"acronym":207,"eligibilityCriteria":208,"healthyVolunteers":203,"sex":209,"minAge":210,"maxAge":211,"enrollmentInfo":212,"targetDuration":35,"studyType":215,"phases":216,"briefSummary":218,"conditions":219,"keywords":221,"overallStatus":108,"whyStopped":35,"lastUpdateSubmitDate":227,"lastUpdatePostDateStruct":228,"startDateStruct":231,"completionDateStruct":233,"leadSponsor":235,"locationsCount":236},{"fullName":5,"class":6},"All India Institute of Medical Sciences","OTHER",[8,15,20,25],{"label":9,"type":10,"description":11,"interventionNames":12},"Fecal Microbiota Transplantation(FMT) with Crohns disease exclusion diet(CDED)","EXPERIMENTAL","1\\. Oral vancomycin 500 mg BD for 3 days before first FMT 2. FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 48 weeks",[13,14],"Other: Fecal Microbial Transplantation","Other: Crohns disease exclusion diet",{"label":16,"type":10,"description":17,"interventionNames":18},"Fecal microbiota transplantation(FMT) and sham diet","1\\. Oral vancomycin 500 mg BD for 3 days before first FMT 2. FMT via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 10 weeks and then 8 weekly during maintenance between 10 to 42 weeks 3. Diet counselling for 48 weeks",[13,19],"Other: Sham diet",{"label":21,"type":10,"description":22,"interventionNames":23},"Crohns Disease Exclusion Diet(CDED) and sham transplantation","1\\. Oral placebo 1 BD for 3 days before first FMT 2. Sham transplantation (clean water) via colonoscopy at 0, 2 and 6 weeks followed by (if treatment responder) 8 weekly during maintenance between 10 to 48 weeks 3.Crohns Disease Exclusion Diet for 48 weeks",[24,14],"Other: Sham transplantation",{"label":26,"type":27,"description":28,"interventionNames":29},"Sham transplantation with Sham diet","SHAM_COMPARATOR","1.Oral placebo 1 BD for 3 days before first sham transplantation 2. Sham colonoscopy with instillation of saline at 0, 2, and 6 weeks followed by (if treatment responder) - 8-weekly during maintenance between 10 to 48 weeks",[24,19],[31,36,40,44],{"type":6,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Fecal Microbial Transplantation","This will involve colonoscopic instillation of fecal transplant",[9,16],null,{"type":6,"name":37,"description":38,"armGroupLabels":39,"otherNames":35},"Sham transplantation","Sham FMT will involve saline infusion via colonoscopy",[21,26],{"type":6,"name":41,"description":42,"armGroupLabels":43,"otherNames":35},"Crohns disease exclusion diet","The modified diet plan will be given to each study participant",[21,9],{"type":6,"name":45,"description":46,"armGroupLabels":47,"otherNames":35},"Sham diet","Dietary counselling alone",[16,26],[49],{"name":50,"affiliation":51,"role":52},"Prof Vineet Ahuja, DM Gastroenterology","Department of Gastroenterology, AIIMS, New Delhi","PRINCIPAL_INVESTIGATOR",[54,58],{"name":50,"role":55,"phone":56,"phoneExt":35,"email":57},"CONTACT","+91-9810707170","vineet.aiims@gmail.com",{"name":59,"role":55,"phone":60,"phoneExt":35,"email":61},"Dr Himanshu Narang, DM Gasteroentrology","+91-8800316504","h92narang@gmail.com",[63,90,106,128,150,166],{"facility":64,"status":65,"city":66,"state":67,"zip":35,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":76},"Department of Gastroenterology, Lisie Hospital","NOT_YET_RECRUITING","Kochi","Kerala","India","IN",{"type":71,"coordinates":72},"Point",[73,74],76.26022,9.93988,{"lat":74,"lon":73},[77,81,85,87],{"name":78,"role":55,"phone":79,"phoneExt":35,"email":80},"Dr Mathew Philip, DM Gasteroentrology","+91-9846045469","drmathewphilip@gmail.com",{"name":82,"role":55,"phone":83,"phoneExt":35,"email":84},"Dr Kiran Josy, DM Gastroentrology","+91-9745243939","drkiranjosy@gmail.com",{"name":86,"role":52,"phone":35,"phoneExt":35,"email":35},"Dr Mathew Philip, DM Gastroenterology",{"name":88,"role":89,"phone":35,"phoneExt":35,"email":35},"Dr Kiran Josy, DM Gastroenterology","SUB_INVESTIGATOR",{"facility":91,"status":65,"city":92,"state":93,"zip":35,"country":68,"countryCode":69,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion","Mumbai","Maharashtra",{"type":71,"coordinates":95},[96,97],72.88261,19.07283,{"lat":97,"lon":96},[100,104],{"name":101,"role":55,"phone":102,"phoneExt":35,"email":103},"Dr Sanjay Chandnani, DM Gasteroentrology","+91-9049708800","sanjy.med@gmail.com",{"name":105,"role":52,"phone":35,"phoneExt":35,"email":35},"Dr Sanjay Chandnani, DM Gastroenterology",{"facility":107,"status":108,"city":109,"state":110,"zip":35,"country":68,"countryCode":69,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences","RECRUITING","New Delhi","National Capital Territory of Delhi",{"type":71,"coordinates":112},[113,114],77.2148,28.62137,{"lat":114,"lon":113},[117,119,121,122,124,126],{"name":118,"role":55,"phone":56,"phoneExt":35,"email":57},"Prof Vineet Ahuja, DM Gasteroentrology",{"name":120,"role":55,"phone":60,"phoneExt":35,"email":61},"Dr Himanshu Narang, DM Gastroentrology",{"name":50,"role":52,"phone":35,"phoneExt":35,"email":35},{"name":123,"role":89,"phone":35,"phoneExt":35,"email":35},"Prof Govind Makharia, DM Gastroenterology",{"name":125,"role":89,"phone":35,"phoneExt":35,"email":35},"Dr Purva Mathur, MD Microbiology",{"name":127,"role":89,"phone":35,"phoneExt":35,"email":35},"Dr Prasenjit Das, MD Pathology",{"facility":129,"status":65,"city":130,"state":131,"zip":35,"country":68,"countryCode":69,"cosmosGeoPoint":132,"geoPoint":136,"contacts":137},"Department of Gastroenterology, Dayanand Medical College","Ludhiana","Punjab",{"type":71,"coordinates":133},[134,135],75.85379,30.91204,{"lat":135,"lon":134},[138,142,146,148],{"name":139,"role":55,"phone":140,"phoneExt":35,"email":141},"Prof Ajit Sood, DM Gasteroentrology","+91-9815400718","ajitsood10@gmail.com",{"name":143,"role":55,"phone":144,"phoneExt":35,"email":145},"Dr Arshdeep Singh, DM Gastroentrology","+91-9815337764","drarshdeepsingh@gmail.com",{"name":147,"role":52,"phone":35,"phoneExt":35,"email":35},"Prof Ajit Sood, DM Gastroenterology",{"name":149,"role":89,"phone":35,"phoneExt":35,"email":35},"Dr Arshdeep Singh, DM Gastroenterology",{"facility":151,"status":65,"city":152,"state":153,"zip":35,"country":68,"countryCode":69,"cosmosGeoPoint":154,"geoPoint":158,"contacts":159},"Department of Gastroentrology, Postgraduate Institute of Medical Education and Research","Chandigarh","Punjab\u002FHaryana",{"type":71,"coordinates":155},[156,157],76.7884,30.73629,{"lat":157,"lon":156},[160,164],{"name":161,"role":55,"phone":162,"phoneExt":35,"email":163},"Dr Vishal Sharma, DM Gasteroentrology","+91-8872813399","docvishalsharma@gmail.com",{"name":165,"role":52,"phone":35,"phoneExt":35,"email":35},"Dr Vishal Sharma, DM Gastroenterology",{"facility":167,"status":65,"city":168,"state":169,"zip":35,"country":68,"countryCode":69,"cosmosGeoPoint":170,"geoPoint":174,"contacts":175},"Department of Gastroenterology, Institute of Medical Sciences, Banaras Hindu University","Varanasi","Uttar Pradesh",{"type":71,"coordinates":171},[172,173],83.01041,25.31668,{"lat":173,"lon":172},[176,180],{"name":177,"role":55,"phone":178,"phoneExt":35,"email":179},"Dr Devesh Prakash Yadav, DM Gasteroentrology","+91-8130856563","devesh.thedoc@gmail.com",{"name":181,"role":52,"phone":35,"phoneExt":35,"email":35},"Dr Devesh Prakash Yadav, DM Gastroenterology",{"type":52,"investigatorFullName":183,"investigatorTitle":184,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"Prof. Vineet Ahuja","Professor",[186,188,190,192,194,196,198],{"name":187,"class":6},"Post Graduate Institute of Medical Education and Research, Chandigarh",{"name":189,"class":6},"Dayanand Medical College and Hospital",{"name":191,"class":6},"Institute of Medical Sciences of the Banaras Hindu University, India",{"name":193,"class":6},"Lokmanya Tilak Municipal Medical College and Hospital",{"name":195,"class":6},"Lisie Hospital",{"name":197,"class":6},"Indraprastha Institute of Information Technology Delhi",{"name":199,"class":200},"Indian Council of Medical Research","OTHER_GOV","100584538","a-study-to-evaluate-the-effect-of-fecal-transplant-and-dietary-changes-on-disease-activity-in-patients-with-newly-diagnosed-active-crohn-disease-100584538",false,"NCT06890650","A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Crohn Disease","Efficacy of Microbiome Manipulation Strategies (fecAL Microbial Transplantation OR CDED OR Both) in Combination Standard Medical Therapy for Induction and Maintenance of Remission in Mild to Moderate tReatment naÃive Active Crohns Disease (ALTER-CD): a Multicentre Double-blind Factorial Randomized Controlled Trial","ALTER-CD","Inclusion Criteria:\n\n1. Patients with treatment-naive Crohns disease accessible with ileocolonoscopy\n2. Symptom onset of less than 12 months\n3. Mild to moderate disease activity with endoscopically active disease\n\n   1. CDAI of greater than 150 and less than 450\n   2. SES-CD of or equal to or greater than 6 (or equal to or greater than 4 if isolated ileal disease)\n4. Aged between 18-75 years\n\nExclusion Criteria:\n\n1. Patients with severe disease (CDAI greater than 450, SES-CD greater than 16) or requiring hospitalization\n2. Patients who have been received on corticosteroids, immunosuppressants (azathioprine\u002F 6- mercaptoprine\u002Fmethotrexate) for greater than 2 weeks\n3. Biologicals or small molecule exposure\n4. Stricturing (non-passable stricture), fistulising phenotype or perianal fistula\u002Fabscess\n5. L4 disease\n6. Pregnant or lactating women\n7. Previous surgery for CD\n8. Declining consent\n9. Not willing for FMT\u002FDietary advise\n10. Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.\n11. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#\n12. 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":213,"type":214},168,"ESTIMATED","INTERVENTIONAL",[217],"NA","Dysbiosis can be rectified by several methods: antibiotics, prebiotics, probiotics, dietary modulation, and fecal microbiota transplantation. There has been limited success with the isolated use of antibiotics and pre\u002Fprobiotics in the treatment of IBD. Among the measures of dietary manipulation, the use of exclusive enteral nutrition (EEN) has shown superior, or at least equivalent, efficacy compared with steroids in pediatric CD. Although the results in adults are not as encouraging, recent cohort studies in patients with complicated CD have shown good success rates. Definite exclusion diets that exclude pro-inflammatory dietary constituents have also been tested with good clinical efficacy in patients with CD, who even failed treatment with anti-TNF agents. Various dietary approaches, inclusive of exclusive enteral nutrition, partial enteral nutrition, and Crohn's disease exclusion diet have been reported to be of benefit and are associated with changes in gut microbiome. Fecal microbiota transplantation (FMT) defined as the infusion of fecal suspension from a healthy individual into the gastrointestinal tract of an individual with GI disease carries a diverse population of microbiota and their metabolites and has been tested with varying efficacy in IBD. In general, FMT has shown good success rates in randomized control trials in patients with UC who failed conventional agents. Although limited small RCTs exist in CD, cohort studies have also shown good success rates. Therefore, the use of FMT in addition to standard medical therapy, is a concept that has not been previously explored and forms the basis for the present study. Therefore, a well-powered RCT is required to resolve the role of FMT in CD. In this study, patients will be recruited in four arms. Group A includes FMT+CDED+SMT, in Group B FMT+SMT+SHAM DIET, in Group C Sham FMT+CDED+SMT, in Group D Sham FMT+ Sham Diet+ SMT given. 168 patients will be recruited across 6 centers for around 3 years. Follow-up of the patient will be done at 0,2,6 and 10 weeks and 8 weekly up to 48 weeks.",[220],"Crohn Disease",[222,223,224,225,226],"Randomized controlled trial","factorial design","Fecal microbiota transplantation","Crohn disease","Crohn disease exclusion diet","2025-04-01",{"date":229,"type":230},"2025-04-04","ACTUAL",{"date":232,"type":230},"2025-03-15",{"date":234,"type":214},"2028-03-15",{"name":5,"class":6},6]