Evaluating fecal transplant and diet changes for ulcerative colitis

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 investigates the effects of fecal microbiota transplantation (FMT) combined with an anti-inflammatory diet on patients with newly diagnosed active ulcerative colitis (UC). It employs a multi-center, double-blind, 2x2 factorial design to randomize treatment-naïve patients into four groups, each receiving different combinations of FMT, dietary interventions, and standard medication (5-ASA). The study aims to assess the impact of these interventions on disease activity and gut microbiota composition. Participants will receive FMT through colonoscopy and follow a specific dietary regimen over several weeks.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Patients with treatment-naive ulcerative colitis of any disease extent. Patients with proctitis will be limited to 25% of the entire pool of patients.
2. Mild to moderate endoscopically active disease (modified Mayo clinic score (mMS) 3-6, with Mayo endoscopic score greater than or equal to 2).
3. Aged between 18-75 years.
4. Patients giving consent for FMT.
5. Patients who agree to adhere to the diet schedule.
6. Patients on oral or topical ASA for less than 4 weeks.
7. Patients on oral steroids/ topical steroids for less than 1 week.
8. Infective colitis should be ruled out by histologic appearance of crypt architecture distortion/basal plasmacytosis, or two sigmoidoscopies, at least 7 days apart showing evidence of endoscopic activity.

Exclusion Criteria:

1. Patients with severe disease (mMS equal to 7-9)
2. Clinical signs of fulminant colitis or toxic megacolon
3. Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns Disease.
4. Patients who have been initiated on other therapies (biologicals or immunosuppressants (azathioprine/ 6-mercaptoprine/methotrexate)) for greater than 2 weeks
5. Patients requiring hospitalization
6. Pregnant or lactating women
7. Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease.
8. Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#
9. 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

• 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.