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 clinical trial is a multi-center, double-blind, factorial randomized controlled trial aimed at assessing the effectiveness of fecal microbiota transplantation (FMT) and a Crohn's Disease Exclusion Diet (CDED) in patients with newly diagnosed, mild to moderate active Crohn's Disease. Participants will receive either FMT, CDED, both, or sham treatments, with the goal of manipulating the gut microbiome to improve disease activity. The trial involves a structured intervention schedule, including a 3-day course of oral vancomycin prior to FMT and multiple FMT sessions over several weeks. The study is conducted across six centers in India, focusing on treatment-naïve patients with specific eligibility criteria.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with treatment-naive Crohns disease accessible with ileocolonoscopy
2. Symptom onset of less than 12 months
3. Mild to moderate disease activity with endoscopically active disease

   1. CDAI of greater than 150 and less than 450
   2. SES-CD of or equal to or greater than 6 (or equal to or greater than 4 if isolated ileal disease)
4. Aged between 18-75 years

Exclusion Criteria:

1. Patients with severe disease (CDAI greater than 450, SES-CD greater than 16) or requiring hospitalization
2. Patients who have been received on corticosteroids, immunosuppressants (azathioprine/ 6- mercaptoprine/methotrexate) for greater than 2 weeks
3. Biologicals or small molecule exposure
4. Stricturing (non-passable stricture), fistulising phenotype or perianal fistula/abscess
5. L4 disease
6. Pregnant or lactating women
7. Previous surgery for CD
8. Declining consent
9. Not willing for FMT/Dietary advise
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 Gastroentrology, Postgraduate Institute of Medical Education and Research
  Chandigarh, Punjab/Haryana, India Not yet recruiting
• Department of Gastroenterology, Institute of Medical Sciences, Banaras Hindu University
  Varanasi, Uttar Pradesh, 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.