A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Ulcerative Colitis

Launched by ALL INDIA INSTITUTE OF MEDICAL SCIENCES, NEW DELHI · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying how fecal microbiota transplantation (FMT) and dietary changes can help people with newly diagnosed active ulcerative colitis (UC), a condition that causes inflammation in the colon and rectum, leading to symptoms like diarrhea and abdominal pain. The trial will compare the effects of FMT combined with an anti-inflammatory diet to a placebo (a treatment that has no active ingredients) and will include patients who are between 18 and 75 years old, have mild to moderate UC, and have not received any other treatments for their condition.

Participants in the trial will receive treatments over 10 weeks, including FMT and dietary guidance, and their progress will be assessed to see if their symptoms improve. Those who respond well will continue in the study for up to 48 weeks. It's important to note that participants will need to commit to following the dietary plan and may need to undergo certain health assessments before joining. This trial offers a chance to explore new treatment options for UC, especially for those who have not yet tried any medications.

Gender

ALL

Eligibility criteria

• 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.