An interventional study of Fecal Microbial Transplantation and Crohns Disease Exclusion Diet in Crohns Disease, sponsored by All India Institute of Medical Sciences, New Delhi. Recruiting at 6 sites in India. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-04-04.
Sponsored by All India Institute of Medical Sciences, New Delhi · Not applicable, Interventional, and Treatment
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/CDED 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
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.
Randomization and Blinding:
Randomization: Centralized, computer-generated randomization using permuted blocks of 8, 12, and 16 to ensure equal distribution across intervention arms.
Stratification: Not more than 1/3rd patients should be biological therapy exposed
Blinding:
The blinded team includes patients and principal investigators. Endoscopists administering FMT/sham FMT and dietitians providing dietary counseling will be unblinded
Sham-Control Methods:
FMT Sham: Sterile clean water infusions via colonoscopy. Diet Sham: Dietary counseling without any modification
Intervention Arms:
Patients are randomized into one of four treatment groups:
FMT + 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)
Fecal Microbiota Transplantation (FMT):
FMT Route: Administered via colonoscopy.
FMT Schedule:
Induction Phase: Weeks 0, 2, and 6. Maintenance Phase: Every 8 weeks (weeks 10, 18, 26, 34, 42) for responders.
Preparation:
Donor Selection: Multi-donor approach with prescreening FMT Processing: 50 g stool freshly prepared and instilled within 4 hours.
Delivery Locations:
Week 0 (Bowel Preparation): Right colon/terminal ileum. Weeks 2 and 6 (No Bowel Preparation): Left colon. Crohn's Disease Exclusion Diet (CDED)
Diet Structure:
Induction Phase (Weeks 0-6): Elimination of specific pro-inflammatory dietary components.
Maintenance Phase (Weeks 6-48): Gradual reintroduction of certain food groups. Monitoring: Adherence tracked using the IBD NutriCare app, diet recall logs, and DietCal software.
Sham Diet: Patients follow a standard healthy diet with general dietary counseling.
Assessments and Data Collection Baseline Assessments (Week 0) Clinical Data: Crohn's Disease Activity Index (CDAI), stool frequency, rectal bleeding, and symptom tracking.
Laboratory Tests:
Hemogram, renal/liver function tests, blood glucose. Inflammatory Markers: C-reactive protein (CRP), erythrocyte sedimentation rate (ESR), fecal calprotectin (FCP).
Microbiome Analysis: Stool samples stored at -80°C for sequencing.
Endoscopic Evaluation:
Scoring: Simple Endoscopic Score for CD (SES-CD). Blinded Central Review: Videos assessed by two independent readers; discrepancies adjudicated by a third reader.
Histology: Biopsies analyzed using DCA score (Distribution Chronicity and Activity).
Follow-up Assessments
Visit Schedule:
Induction 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
Adverse Event (AE) Classification:
CTCAE Grading (Grade 1-5) for treatment-related AEs. Serious Adverse Events (SAEs): Hospitalization, life-threatening events, or disability.
Safety Monitoring Plan:
Pre-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
Electronic Data Capture (EDC):
Platform: REDCap database with tiered access permissions. Audit Trails: Secure logs of data entry and modification.
Dietary Data Processing:
IBD NutriCare app logs converted into macronutrient composition reports. Adherence scoring based on 80% compliance threshold.
Microbiome Data Processing:
Samples sequenced at IIIT-Delhi, analyzed for diversity indices and metabolic pathways.
Statistical Plan:
Primary Analysis: Intention-to-treat (ITT) and per-protocol (PP) analyses. Longitudinal Modeling: Mixed-effects models for repeated measures.
Effect Size Estimation:
Sample size: 168 patients (42 per arm).
1,992 studies on the registry are indexed under Crohn Disease; 478 are open to participants now.
This study's planned enrollment of 168 is above the median of 67 across 1,260 interventional studies indexed under Crohn Disease.
Browse Crohn Disease studies →All India Institute of Medical Sciences, New Delhi is the lead sponsor of 143 studies on the registry; 13 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Those with negative assay and persistent activity will be included in the study
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Other: Fecal Microbial Transplantation · Other: Crohns Disease Exclusion Diet · Other: 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
Other: Fecal Microbial Transplantation · Other: Sham Diet · Other: 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
Other: Crohns Disease Exclusion Diet · Other: Sham transplantation · Other: 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. Dietary counselling throughout the study 3. Advanced therapy as standard dose and schedule.
Other: Sham transplantation · Other: Sham Diet · Other: Advanced therapy
This will involve colonoscopic instillation of fecal transplant
The modified diet plan will be given to each study participant
Sham transplantation will involve saline infusion via colonoscopy
Dietary counselling alone
Advanced therapy as standard dose and schedule
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%)
Time frame: 10 weeks
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)
Time frame: 48 weeks
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
Time frame: 10 weeks
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
Time frame: 10 weeks
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
Time frame: 10 weeks
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
Time frame: 10 weeks
Proportion of patients with biomarker remission at Week 10
Proportion of patients with biomarker remission which is defined as fecal calprotectin ≤150 mcg/g
Time frame: 10 weeks
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))
Time frame: 10 weeks
Proportion of patients with clinical response at Week 48
Proportion of patients with clinical response is defined as either CDAI decrease from baseline of at least 70 points or CDAI less than 150
Time frame: 48 weeks
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
Time frame: 48 weeks
Proportion of patients with endoscopic response at Week 48
Proportion of patients with endoscopic response defined as 50% reduction from baseline on SES-CD
Time frame: 48 weeks
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
Time frame: 48 weeks
Proportion of patients with corticosteroid-free clinical remission at Week 48
Proportion of patients with corticosteroid-free clinical remission is defined as the CDAI\<150 with no exposure to steroids over the previous 8 weeks
Time frame: 48 weeks
Fecal microbiome and metabolite signature between responders and non-responders at Week 48
It involves combined analysis of the microorganisms (bacteria, viruses, fungi, etc.) and the small molecules (metabolites) present in a person's stool sample
Time frame: 48 weeks
Proportion of patients with biomarker remission at Week 48
Proportion of patients with biomarker remission which is defined as fecal calprotectin ≤150 mcg/g
Time frame: 48 weeks
Proportion of patients with adverse event at Week 48
Proportion of Patients Experiencing Adverse Events (will be assessed according to common criteria for adverse events (CTCEA))
Time frame: 48 weeks
Proportion of patients with adverse event at Week 6
Proportion of Patients Experiencing Adverse Events (will be assessed according to common criteria for adverse events (CTCEA))
Time frame: 6 weeks
Proportion of Patients Experiencing Adverse Events at Week 26
Proportion of Patients Experiencing Adverse Events (will be assessed according to common criteria for adverse events (CTCEA))
Time frame: 26 weeks
Plan to share: No
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All India Institute of Medical Sciences, New Delhi →