[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100584537":3},{"organization":4,"outcomesModule":7,"designInfo":63,"detailedDescription":72,"studyPopulation":62,"armGroups":73,"interventions":97,"overallOfficials":118,"centralContacts":123,"locations":132,"responsibleParty":245,"collaborators":62,"id":248,"slug":62,"hasResults":249,"nctId":250,"briefTitle":251,"officialTitle":252,"acronym":253,"eligibilityCriteria":254,"healthyVolunteers":249,"sex":255,"minAge":256,"maxAge":257,"enrollmentInfo":258,"targetDuration":62,"studyType":261,"phases":262,"briefSummary":264,"conditions":265,"keywords":267,"overallStatus":175,"whyStopped":62,"lastUpdateSubmitDate":272,"lastUpdatePostDateStruct":273,"startDateStruct":276,"completionDateStruct":278,"leadSponsor":280,"locationsCount":281},{"fullName":5,"class":6},"All India Institute of Medical Sciences","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":17,"otherOutcomes":62},[9,13],{"measure":10,"description":11,"timeFrame":12},"Proportion of patients with clinical remission and endoscopic response at week 10","Proportion of patients with clinical remission (defined as CDAI less than 150) and endoscopic response( defined decline in SES-CD by greater than 50%)","10 weeks",{"measure":14,"description":15,"timeFrame":16},"Proportion of patients with clinical remission and endoscopic remission at week 10","Proportion of patients with clinical remission (defined as Crohn's disease activity index less than 150) and endoscopic remission (defined as Simple Endoscopic Score for Crohn's disease patients less than 3)","48 weeks",[18,21,24,27,30,33,36,38,41,44,47,50,52,54,56,59],{"measure":19,"description":20,"timeFrame":12},"Proportion of patients with clinical response at Week 10","Proportion of patients with clinical response is defined as either CDAI decrease from baseline of at least 70 points or CDAI less than 150",{"measure":22,"description":23,"timeFrame":12},"Proportion of patients with PRO2 Remission at Week 10","Proportion of patients with PRO2 Remission which is defined as Abdominal pain subscore of not more than 1 (on a scale of 0-3) and liquid or very soft stool (Bristol stool scale type 6 or 7) frequency subscore of not more than 3 calculated as a mean of 7 day count",{"measure":25,"description":26,"timeFrame":12},"Proportion of patients with endoscopic response at Week 10","Proportion of patients with endoscopic response which is defined as 50% reduction from baseline on SES-CD",{"measure":28,"description":29,"timeFrame":12},"Fecal microbiome and metabolite signature between responders and non-responders at week 10","It involves combined analysis of the microorganisms (bacteria, viruses, fungi, etc.) and the small molecules (metabolites) present in a person's stool sample",{"measure":31,"description":32,"timeFrame":12},"Proportion of patients with biomarker remission at Week 10","Proportion of patients with biomarker remission which is defined as fecal calprotectin ≤150 mcg\u002Fg",{"measure":34,"description":35,"timeFrame":12},"Proportion of patients with adverse events at Week 10","Proportion of Patients Experiencing Adverse Events (will be assessed according to common criteria for adverse events (CTCEA))",{"measure":37,"description":20,"timeFrame":16},"Proportion of patients with clinical response at Week 48",{"measure":39,"description":40,"timeFrame":16},"Proportion of patients with PRO2 remission at Week 48","Proportion of patients with PRO2 remission is defined as Abdominal pain subscore of not more than 1 (on a scale of 0-3) and liquid or very soft stool (Bristol stool scale type 6 or 7) frequency subscore of not more than 3 calculated as a mean of 7 day count",{"measure":42,"description":43,"timeFrame":16},"Proportion of patients with endoscopic response at Week 48","Proportion of patients with endoscopic response defined as 50% reduction from baseline on SES-CD",{"measure":45,"description":46,"timeFrame":16},"Proportion of patients with Endoscopic remission at Week 48 weeks","Proportion of patients with Endoscopic remission defined as a SES-CD score of 2 or less",{"measure":48,"description":49,"timeFrame":16},"Proportion of patients with corticosteroid-free clinical remission at Week 48","Proportion of patients with corticosteroid-free clinical remission is defined as the CDAI\\\u003C150 with no exposure to steroids over the previous 8 weeks",{"measure":51,"description":29,"timeFrame":16},"Fecal microbiome and metabolite signature between responders and non-responders at Week 48",{"measure":53,"description":32,"timeFrame":16},"Proportion of patients with biomarker remission at Week 48",{"measure":55,"description":35,"timeFrame":16},"Proportion of patients with adverse event at Week 48",{"measure":57,"description":35,"timeFrame":58},"Proportion of patients with adverse event at Week 6","6 weeks",{"measure":60,"description":35,"timeFrame":61},"Proportion of Patients Experiencing Adverse Events at Week 26","26 weeks",null,{"allocation":64,"interventionModel":65,"interventionModelDescription":62,"primaryPurpose":66,"observationalModel":62,"timePerspective":62,"maskingInfo":67},"RANDOMIZED","FACTORIAL","TREATMENT",{"masking":68,"maskingDescription":62,"whoMasked":69},"DOUBLE",[70,71],"PARTICIPANT","INVESTIGATOR","This is a multicenter, double-blind, factorial randomized controlled trial (RCT) evaluating the efficacy of microbiome manipulation strategies in patients with active Crohn's Disease (CD) undergoing advanced therapy (biologics or small molecules). The study will be conducted across six clinical centers in India, with an additional center designated for microbiome analysis.\n\nRandomization and Blinding:\n\nRandomization: Centralized, computer-generated randomization using permuted blocks of 8, 12, and 16 to ensure equal distribution across intervention arms.\n\nStratification: Not more than 1\u002F3rd patients should be biological therapy exposed\n\nBlinding:\n\nThe blinded team includes patients and principal investigators. Endoscopists administering FMT\u002Fsham FMT and dietitians providing dietary counseling will be unblinded\n\nSham-Control Methods:\n\nFMT Sham: Sterile clean water infusions via colonoscopy. Diet Sham: Dietary counseling without any modification\n\nIntervention Arms:\n\nPatients are randomized into one of four treatment groups:\n\nFMT + CDED + Advanced Therapy (Group A) FMT + Sham Diet + Advanced Therapy (Group B) Sham FMT + CDED + Advanced Therapy (Group C) Sham FMT + Sham Diet + Advanced Therapy (Group D)\n\nFecal Microbiota Transplantation (FMT):\n\nFMT Route: Administered via colonoscopy.\n\nFMT Schedule:\n\nInduction Phase: Weeks 0, 2, and 6. Maintenance Phase: Every 8 weeks (weeks 10, 18, 26, 34, 42) for responders.\n\nPreparation:\n\nDonor Selection: Multi-donor approach with prescreening FMT Processing: 50 g stool freshly prepared and instilled within 4 hours.\n\nDelivery Locations:\n\nWeek 0 (Bowel Preparation): Right colon\u002Fterminal ileum. Weeks 2 and 6 (No Bowel Preparation): Left colon. Crohn's Disease Exclusion Diet (CDED)\n\nDiet Structure:\n\nInduction Phase (Weeks 0-6): Elimination of specific pro-inflammatory dietary components.\n\nMaintenance Phase (Weeks 6-48): Gradual reintroduction of certain food groups. Monitoring: Adherence tracked using the IBD NutriCare app, diet recall logs, and DietCal software.\n\nSham Diet: Patients follow a standard healthy diet with general dietary counseling.\n\nAssessments and Data Collection Baseline Assessments (Week 0) Clinical Data: Crohn's Disease Activity Index (CDAI), stool frequency, rectal bleeding, and symptom tracking.\n\nLaboratory Tests:\n\nHemogram, renal\u002Fliver function tests, blood glucose. Inflammatory Markers: C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fecal calprotectin (FCP).\n\nMicrobiome Analysis: Stool samples stored at -80°C for sequencing.\n\nEndoscopic Evaluation:\n\nScoring: Simple Endoscopic Score for CD (SES-CD). Blinded Central Review: Videos assessed by two independent readers; discrepancies adjudicated by a third reader.\n\nHistology: Biopsies analyzed using DCA score (Distribution Chronicity and Activity).\n\nFollow-up Assessments\n\nVisit Schedule:\n\nInduction Phase: Weeks 2, 4, 6, and 10. Maintenance Phase: Every 8 weeks (weeks 18, 26, 34, 42, and 48). Clinical Assessments: CDAI, PRO2 symptom tracking, medication adherence checks. Endoscopy: Week 10 and Week 48; central scoring of videos. Diet Adherence: Assessed at weeks 2, 4, 6, and 10, then every 8 weeks. Microbiome Sampling: Stool samples collected at weeks 10 and 48. Safety Monitoring and Adverse Events\n\nAdverse Event (AE) Classification:\n\nCTCAE Grading (Grade 1-5) for treatment-related AEs. Serious Adverse Events (SAEs): Hospitalization, life-threatening events, or disability.\n\nSafety Monitoring Plan:\n\nPre-procedural safety checks for each FMT session. Immediate post-FMT monitoring (48 hours). Late safety assessments (14 days post-FMT, then every visit). Unblinding Procedure: Allowed only for SAE management with DSMB approval. Data Management and Statistical Analysis\n\nElectronic Data Capture (EDC):\n\nPlatform: REDCap database with tiered access permissions. Audit Trails: Secure logs of data entry and modification.\n\nDietary Data Processing:\n\nIBD NutriCare app logs converted into macronutrient composition reports. Adherence scoring based on 80% compliance threshold.\n\nMicrobiome Data Processing:\n\nSamples sequenced at IIIT-Delhi, analyzed for diversity indices and metabolic pathways.\n\nStatistical Plan:\n\nPrimary Analysis: Intention-to-treat (ITT) and per-protocol (PP) analyses. Longitudinal Modeling: Mixed-effects models for repeated measures.\n\nEffect Size Estimation:\n\nSample size: 168 patients (42 per arm).",[74,82,87,92],{"label":75,"type":76,"description":77,"interventionNames":78},"Fecal microbiota transplantation(FMT) with Crohns disease exclusion diet (CDED) and advanced therapy","EXPERIMENTAL","1\\. FMT via colonoscopy at 0, 2 and 6 weeks (preceded by 3 days antibiotics, only before first procedure) followed by (if treatment responder) 8 weekly during maintenance till 42 weeks 2. Crohn disease exclusion diet(CDED) throughout the study 3. Advanced therapy as standard dose and schedule",[79,80,81],"Other: Fecal Microbial Transplantation","Other: Crohns Disease Exclusion Diet","Other: Advanced therapy",{"label":83,"type":76,"description":84,"interventionNames":85},"Fecal microbiota transplantation (FMT) with sham diet and Advanced therapy","1\\. FMT via colonoscopy at 0, 2 and 6 weeks (preceded by 3 days antibiotics, only before first procedure) followed by (if treatment responder) 8 weekly during maintenance till 42 weeks 2. Dietary counselling throughout the study 3. Advanced therapy as standard dose and schedule",[79,86,81],"Other: Sham Diet",{"label":88,"type":76,"description":89,"interventionNames":90},"Sham FMT with Crohns disease exclusion diet (CDED) and advanced therapy","1\\. Sham FMT with instillation of clean water at 0, 2 and 6 weeks (preceded by 3 days antibiotics, only before first procedure) followed by (if treatment responder) - 8- weekly during maintenance till 42 weeks 2. CDED throughout the study 3. Advanced therapy as standard dose and schedule",[80,91,81],"Other: Sham transplantation",{"label":93,"type":94,"description":95,"interventionNames":96},"Sham Diet with Sham FMT with advance therapy","SHAM_COMPARATOR","1.Sham FMT with instillation of clean water at 0, 2 and 6 weeks (preceded by 3 days antibiotics, only before first procedure) followed by (if treatment responder) - 8- weekly during maintenance till 42 weeks 2. Dietary counselling throughout the study 3. Advanced therapy as standard dose and schedule.",[91,86,81],[98,102,106,110,114],{"type":6,"name":99,"description":100,"armGroupLabels":101,"otherNames":62},"Fecal Microbial Transplantation","This will involve colonoscopic instillation of fecal transplant",[83,75],{"type":6,"name":103,"description":104,"armGroupLabels":105,"otherNames":62},"Crohns Disease Exclusion Diet","The modified diet plan will be given to each study participant",[75,88],{"type":6,"name":107,"description":108,"armGroupLabels":109,"otherNames":62},"Sham transplantation","Sham transplantation will involve saline infusion via colonoscopy",[93,88],{"type":6,"name":111,"description":112,"armGroupLabels":113,"otherNames":62},"Sham Diet","Dietary counselling alone",[83,93],{"type":6,"name":115,"description":116,"armGroupLabels":117,"otherNames":62},"Advanced therapy","Advanced therapy as standard dose and schedule",[83,75,93,88],[119],{"name":120,"affiliation":121,"role":122},"Prof Vineet Ahuja, DM Gastroenterology","Department of Gastroenterology, AIIMS, New Delhi","PRINCIPAL_INVESTIGATOR",[124,128],{"name":120,"role":125,"phone":126,"phoneExt":62,"email":127},"CONTACT","+91-9810707170","vineet.aiims@gmail.com",{"name":129,"role":125,"phone":130,"phoneExt":62,"email":131},"Dr Himanshu Narang, DM Gasteroentrology","+91-8800316504","h92narang@gmail.com",[133,158,173,195,215,230],{"facility":134,"status":135,"city":136,"state":137,"zip":62,"country":138,"countryCode":139,"cosmosGeoPoint":140,"geoPoint":145,"contacts":146},"Department of Gastroenterology, Lisie Hospital","NOT_YET_RECRUITING","Kochi","Kerala","India","IN",{"type":141,"coordinates":142},"Point",[143,144],76.26022,9.93988,{"lat":144,"lon":143},[147,151,155,156],{"name":148,"role":125,"phone":149,"phoneExt":62,"email":150},"Dr Mathew Philip, DM Gastroenterology","+91-9846045469","drmathewphilip@gmail.com",{"name":152,"role":125,"phone":153,"phoneExt":62,"email":154},"Dr Kiran Josy, DM Gastroenterology","+91-9745243939","drkiranjosy@gmail.com",{"name":148,"role":122,"phone":62,"phoneExt":62,"email":62},{"name":152,"role":157,"phone":62,"phoneExt":62,"email":62},"SUB_INVESTIGATOR",{"facility":159,"status":135,"city":160,"state":161,"zip":62,"country":138,"countryCode":139,"cosmosGeoPoint":162,"geoPoint":166,"contacts":167},"Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion","Mumbai","Maharashtra",{"type":141,"coordinates":163},[164,165],72.88261,19.07283,{"lat":165,"lon":164},[168,172],{"name":169,"role":125,"phone":170,"phoneExt":62,"email":171},"Dr Sanjay Chandnani, DM Gastroenterology","+91-9049708800","sanjy.med@gmail.com",{"name":169,"role":122,"phone":62,"phoneExt":62,"email":62},{"facility":174,"status":175,"city":176,"state":177,"zip":62,"country":138,"countryCode":139,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences","RECRUITING","New Delhi","National Capital Territory of Delhi",{"type":141,"coordinates":179},[180,181],77.2148,28.62137,{"lat":181,"lon":180},[184,186,188,189,191,193],{"name":185,"role":125,"phone":126,"phoneExt":62,"email":127},"Prof Vineet Ahuja, DM Gasteroentrology",{"name":187,"role":125,"phone":130,"phoneExt":62,"email":131},"Dr Himanshu Narang, DM Gastroentrology",{"name":120,"role":122,"phone":62,"phoneExt":62,"email":62},{"name":190,"role":157,"phone":62,"phoneExt":62,"email":62},"Prof Govind Makharia, DM Gastroenterology",{"name":192,"role":157,"phone":62,"phoneExt":62,"email":62},"Dr Purva Mathur, MD Microbiology",{"name":194,"role":157,"phone":62,"phoneExt":62,"email":62},"Dr Prasenjit Das, MD Pathology",{"facility":196,"status":135,"city":197,"state":198,"zip":62,"country":138,"countryCode":139,"cosmosGeoPoint":199,"geoPoint":203,"contacts":204},"Department of Gastroenterology, Dayanand Medical College","Ludhiana","Punjab",{"type":141,"coordinates":200},[201,202],75.85379,30.91204,{"lat":202,"lon":201},[205,209,213,214],{"name":206,"role":125,"phone":207,"phoneExt":62,"email":208},"Prof Ajit Sood, DM Gastroenterology","+91-9815400718","ajitsood10@gmail.com",{"name":210,"role":125,"phone":211,"phoneExt":62,"email":212},"Dr Arshdeep Singh, DM Gastroenterology","+91-9815337764","drarshdeepsingh@gmail.com",{"name":206,"role":122,"phone":62,"phoneExt":62,"email":62},{"name":210,"role":157,"phone":62,"phoneExt":62,"email":62},{"facility":216,"status":135,"city":217,"state":218,"zip":62,"country":138,"countryCode":139,"cosmosGeoPoint":219,"geoPoint":223,"contacts":224},"Department of Gastroenterology, Institute of Medical Sciences","Varanasi","Uttar Pradesh",{"type":141,"coordinates":220},[221,222],83.01041,25.31668,{"lat":222,"lon":221},[225,229],{"name":226,"role":125,"phone":227,"phoneExt":62,"email":228},"Dr Devesh Prakash Yadav, DM Gastroenterology","+91-8130856563","devesh.thedoc@gmail.com",{"name":226,"role":122,"phone":62,"phoneExt":62,"email":62},{"facility":231,"status":135,"city":232,"state":62,"zip":62,"country":138,"countryCode":139,"cosmosGeoPoint":233,"geoPoint":237,"contacts":238},"Department of Gastroentrology, Postgraduate Institute of Medical Education and Research","Chandigarh",{"type":141,"coordinates":234},[235,236],76.7884,30.73629,{"lat":236,"lon":235},[239,243],{"name":240,"role":125,"phone":241,"phoneExt":62,"email":242},"Dr Vishal Sharma, DM Gasteroentrology","+91-8872813399","docvishalsharma@gmail.com",{"name":244,"role":122,"phone":62,"phoneExt":62,"email":62},"Dr Vishal Sharma, DM Gastroenterology",{"type":122,"investigatorFullName":246,"investigatorTitle":247,"investigatorAffiliation":5,"oldNameTitle":62,"oldOrganization":62},"Prof. Vineet Ahuja","Professor","100584537",false,"NCT06890637","A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Crohn Disease on Advanced Therapies","Efficacy of Microbiome Manipulation Strategies (Fecal Microbial Transplant or Crohns Disease Exclusion Diet or Both) With Advanced Therapies (BiOlOgics and Small Molecules) to Break the Therapeutic Ceiling in Active Crohns Disease (BOOST-CD): A Multicenter Double Blind Factorial Randomized Controlled Trial","BOOST-CD","Inclusion Criteria:\n\n1. Patients with active Crohn disease in whom FMT is feasible\n2. Active Crohn's disease who are candidates for advanced therapy (steroid refractory, Immunomodulator intolerant or refractory and moderately severe disease at the time of inclusion) or patients who have an intolerance to or have lost response to advanced therapies must have had their last treatment at least five half-lives prior randomization.\n3. Aged between 18-75 years\n4. CDAI greater than 150 and\u002For SES-CD equal or greater than 6 (or equal or greater than 4 if isolated ileal disease)\n\nExclusion Criteria:\n\n1. Patients in remission (CDAI less than 150)\n2. Stricturing disease (non-passable stricture) in whom FMT is not feasible\n3. Fistulising phenotype or Perianal fistula or abscess\n4. Isolated L4 disease\n5. Active TB or Sepsis\n6. Pregnant or lactating women\n7. Patients with co-morbidities like CAD\u002FCLD\u002FCKD\n8. Previous surgery for CD\n9. Declining consent or not willing for FMT or diet advice\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.\n\nThose with negative assay and persistent activity will be included in the study","ALL","18 Years","75 Years",{"count":259,"type":260},168,"ESTIMATED","INTERVENTIONAL",[263],"NA","Advanced therapies including biologics and small molecules target specific inflammatory pathways. IBD's multifactorial etiology means that blocking a single pathway may not be sufficient for all patients. Even when combination of advanced therapies are used, the incremental benefits often diminish, reflecting the therapeutic ceiling. Furthermore, safety concerns also limit the potential to push beyond this ceiling. Increasing the dose or adding more immunosuppressive agents can lead to a higher risk of infections, malignancies, and other adverse effects, making it impractical to continually intensify treatment. Understanding the therapeutic ceiling in IBD highlights the need for innovative approaches that go beyond current strategies. Given the diverse microbial and immunological landscapes in IBD combining fecal microbiota transplantation (FMT) and Crohn's Disease Exclusion Diet (CDED) with advanced therapies represents a promising approach to break the therapeutic ceiling in CD. This strategy leverages the complementary mechanisms of action of FMT\u002FCDED and advance therapies, potentially offering a more comprehensive treatment modality that addresses the complex and multifactorial nature of IBD. FMT involves the transfer of gut microbiota from a healthy donor to a patient, aiming to restore a balanced microbial community in the intestines. This can help modulate the immune system and reduce inflammation, which are central to Crohn's disease pathology. This study seeks to provide evidence on whether addition of microbiota manipulation by FMT and CDED offers additional benefits when used alongside advance therapies in active CD. The findings from this RCT are expected to significantly enhance treatment strategies, ensuring that patients receive the most effective and appropriate care based on robust scientific evidence. This multi-center double blind placebo-controlled RCT will randomize patients in 1:1:1:1 ratio to FMT, CDED and advance therapy vs sham FMT with advance therapy and CDED vs FMT, Advance therapy and sham diet vs Advance therapy with sham FMT and sham diet for induction and maintenance of remission in patients of active Crohn's disease. Randomization will be held centrally to ensure concealment of allocation. Random numbers will be generated by computerized random number schedule (The RAND), and the randomization list and numbered packing of the intervention will be prepared by a person not involved in the study. Randomization will be performed using permuted blocks of 8. Both the patient and the investigator will be blinded to the intervention",[266],"Crohns Disease",[268,269,99,270,271,115],"Randomized Controlled Trial","Factorial Design","Crohns disease exclusion diet","Crohns disease","2025-04-01",{"date":274,"type":275},"2025-04-04","ACTUAL",{"date":277,"type":275},"2025-03-15",{"date":279,"type":260},"2028-03-15",{"name":5,"class":6},6]