Status:
RECRUITING
A Study to Evaluate the Effect of Fecal Transplant and Dietary Changes on Disease Activity in Patients With Newly Diagnosed Active Ulcerative Colitis
Lead Sponsor:
All India Institute of Medical Sciences
Collaborating Sponsors:
Post Graduate Institute of Medical Education and Research, Chandigarh
Institute of Medical Sciences of the Banaras Hindu University, India
Conditions:
Ulcerative Colitis (UC)
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
Ulcerative colitis (UC) is a chronic inflammatory condition affecting the colon and rectum, characterized by mucosal inflammation and symptomslike diarrhea, abdominal pain, and rectal bleeding. It is ...
Detailed Description
This study is a multi-center, double-blind, 2 × 2 factorial, randomized sham-controlled trial designed to evaluate the effects of fecal microbiota transplantation (FMT) and dietary modification in tre...
Eligibility Criteria
Inclusion
- Patients with treatment-naive ulcerative colitis of any disease extent. Patients with proctitis will be limited to 25% of the entire pool of patients.
- Mild to moderate endoscopically active disease (modified Mayo clinic score (mMS) 3-6, with Mayo endoscopic score greater than or equal to 2).
- Aged between 18-75 years.
- Patients giving consent for FMT.
- Patients who agree to adhere to the diet schedule.
- Patients on oral or topical ASA for less than 4 weeks.
- Patients on oral steroids/ topical steroids for less than 1 week.
- 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
- Patients with severe disease (mMS equal to 7-9)
- Clinical signs of fulminant colitis or toxic megacolon
- Presence of IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohns Disease.
- Patients who have been initiated on other therapies (biologicals or immunosuppressants (azathioprine/ 6-mercaptoprine/methotrexate)) for greater than 2 weeks
- Patients requiring hospitalization
- Pregnant or lactating women
- Patients with current or recent history of clinically severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac or neurological disease.
- Positive assay or stool culture for pathogens (ova and parasite examination, bacteria) or positive test for Clostridioides difficile toxin at screening#
- 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.
Key Trial Info
Start Date :
March 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 15 2028
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT06895252
Start Date
March 15 2025
End Date
March 15 2028
Last Update
April 4 2025
Active Locations (6)
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1
Department of Gastroenterology, Lisie Hospital
Kochi, Kerala, India
2
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
Mumbai, Maharashtra, India
3
Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, India, 110029
4
Department of Gastroenterology, Dayanand Medical College
Ludhiana, Punjab, India