Status:
RECRUITING
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Crohn Disease on Advanced Therapies
Lead Sponsor:
All India Institute of Medical Sciences
Conditions:
Crohns Disease
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
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 patie...
Detailed Description
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 a...
Eligibility Criteria
Inclusion
- Patients with active Crohn disease in whom FMT is feasible
- 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.
- Aged between 18-75 years
- CDAI greater than 150 and/or SES-CD equal or greater than 6 (or equal or greater than 4 if isolated ileal disease)
Exclusion
- Patients in remission (CDAI less than 150)
- Stricturing disease (non-passable stricture) in whom FMT is not feasible
- Fistulising phenotype or Perianal fistula or abscess
- Isolated L4 disease
- Active TB or Sepsis
- Pregnant or lactating women
- Patients with co-morbidities like CAD/CLD/CKD
- Previous surgery for CD
- Declining consent or not willing for FMT or diet advice
- Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, or neurological disease.
- Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#
- 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
Key Trial Info
Start Date :
March 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2028
Estimated Enrollment :
168 Patients enrolled
Trial Details
Trial ID
NCT06890637
Start Date
March 15 2025
End Date
March 15 2028
Last Update
April 4 2025
Active Locations (6)
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1
Department of Gastroenterology, Lisie Hospital
Kochi, Kerala, India
2
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
Mumbai, Maharashtra, India
3
Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India
4
Department of Gastroenterology, Dayanand Medical College
Ludhiana, Punjab, India