A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Crohn Disease on Advanced Therapies
NCT ID: NCT06890637
Last Updated: 2025-04-04
Study Results
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Basic Information
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RECRUITING
NA
168 participants
INTERVENTIONAL
2025-03-15
2028-03-15
Brief Summary
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Detailed Description
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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).
Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
DOUBLE
Study Groups
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Fecal microbiota transplantation(FMT) with Crohns disease exclusion diet (CDED) 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. Crohn disease exclusion diet(CDED) throughout the study 3. Advanced therapy as standard dose and schedule
Fecal Microbial Transplantation
This will involve colonoscopic instillation of fecal transplant
Crohns Disease Exclusion Diet
The modified diet plan will be given to each study participant
Advanced therapy
Advanced therapy as standard dose and schedule
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
Fecal Microbial Transplantation
This will involve colonoscopic instillation of fecal transplant
Sham Diet
Dietary counselling alone
Advanced therapy
Advanced therapy as standard dose and schedule
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
Crohns Disease Exclusion Diet
The modified diet plan will be given to each study participant
Sham transplantation
Sham transplantation will involve saline infusion via colonoscopy
Advanced therapy
Advanced therapy as standard dose and schedule
Sham Diet with Sham FMT with advance 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.
Sham transplantation
Sham transplantation will involve saline infusion via colonoscopy
Sham Diet
Dietary counselling alone
Advanced therapy
Advanced therapy as standard dose and schedule
Interventions
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Fecal Microbial Transplantation
This will involve colonoscopic instillation of fecal transplant
Crohns Disease Exclusion Diet
The modified diet plan will be given to each study participant
Sham transplantation
Sham transplantation will involve saline infusion via colonoscopy
Sham Diet
Dietary counselling alone
Advanced therapy
Advanced therapy as standard dose and schedule
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Aged between 18-75 years
4. CDAI greater than 150 and/or SES-CD equal or greater than 6 (or equal or greater than 4 if isolated ileal disease)
Exclusion Criteria
2. Stricturing disease (non-passable stricture) in whom FMT is not feasible
3. Fistulising phenotype or Perianal fistula or abscess
4. Isolated L4 disease
5. Active TB or Sepsis
6. Pregnant or lactating women
7. Patients with co-morbidities like CAD/CLD/CKD
8. Previous surgery for CD
9. Declining consent or not willing for FMT or diet advice
10. Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
11. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#
12. 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
18 Years
75 Years
ALL
No
Sponsors
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All India Institute of Medical Sciences
OTHER
Responsible Party
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Prof. Vineet Ahuja
Professor
Principal Investigators
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Prof Vineet Ahuja, DM Gastroenterology
Role: PRINCIPAL_INVESTIGATOR
Department of Gastroenterology, AIIMS, New Delhi
Locations
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Department of Gastroenterology, Lisie Hospital
Kochi, Kerala, India
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
Mumbai, Maharashtra, India
Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
Department of Gastroenterology, Dayanand Medical College
Ludhiana, Punjab, India
Department of Gastroenterology, Institute of Medical Sciences
Varanasi, Uttar Pradesh, India
Department of Gastroentrology, Postgraduate Institute of Medical Education and Research
Chandigarh, , India
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AIIMSA2988/03.01.2025
Identifier Type: -
Identifier Source: org_study_id
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