Evaluating Fecal Transplant and Diet Changes for Crohn's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
  New Delhi, National Capital Territory of Delhi, India Recruiting
• 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, 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
• Email: vineet.aiims@gmail.com
• Phone: +91-9810707170

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.