Evaluating Fecal Transplant and Diet Changes for Crohn's Disease

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

This study is testing if combining a special diet with fecal transplants can help people with active Crohn's Disease feel better while they are on other treatments.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 168 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: All India Institute of Medical Sciences (Academic / other)
• Locations: 6 sites (Kochi, Kerala and 5 other locations)
• Trial ID: NCT06890637 on ClinicalTrials.gov

What this trial studies

This multicenter, double-blind, factorial randomized controlled trial aims to assess the effectiveness of fecal microbiota transplantation (FMT) combined with a Crohn's Disease Exclusion Diet (CDED) in patients with active Crohn's Disease who are undergoing advanced therapies. Participants will be randomized into four groups to receive different combinations of FMT, sham FMT, CDED, and sham diet, alongside their ongoing advanced therapy. The study will be conducted across six clinical centers in India, with a focus on understanding how these interventions can improve disease activity and potentially break the therapeutic ceiling in Crohn's Disease management.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with active Crohn's Disease who are candidates for advanced therapy and have not responded to or are intolerant to previous treatments.

Not a fit: Patients in remission, those with stricturing disease, or those with certain comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a novel treatment option that enhances the effectiveness of existing therapies for patients with Crohn's Disease.

How similar studies have performed: While the combination of FMT and dietary interventions is a novel approach, previous studies have shown promise in using FMT for inflammatory bowel diseases, indicating potential for success.

Eligibility criteria

Inclusion Criteria:

1. Patients with active Crohn disease in whom FMT is feasible
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:

1. Patients in remission (CDAI less than 150)
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

Where this trial is running

Kochi, Kerala and 5 other locations

• Department of Gastroenterology, Lisie Hospital — Kochi, Kerala, India (Not_yet_recruiting)
• Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion — Mumbai, Maharashtra, India (Not_yet_recruiting)
• Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences — New Delhi, National Capital Territory of Delhi, India (Recruiting)
• Department of Gastroenterology, Dayanand Medical College — Ludhiana, Punjab, India (Not_yet_recruiting)
• Department of Gastroenterology, Institute of Medical Sciences — Varanasi, Uttar Pradesh, India (Not_yet_recruiting)
• Department of Gastroentrology, Postgraduate Institute of Medical Education and Research — Chandigarh, India (Not_yet_recruiting)

Study contacts

• Principal investigator: Prof Vineet Ahuja, DM Gastroenterology — Department of Gastroenterology, AIIMS, New Delhi
• Study coordinator: Prof Vineet Ahuja, DM Gastroenterology

Conditions Crohns Disease; Randomized Controlled Trial; Factorial Design; Fecal Microbial Transplantation; Crohns disease exclusion diet; Crohns disease; Advanced therapy