AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingNAAges 18 Years - 75 YearsAllAll India Institute of Medical Sciences
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 a subtype of inflammatory bowel disease (IBD) and results from a combination of genetic predisposition, environmental factors, and immune dysregulation. UC is associated with significant gut microbiota dysbiosis, marked by reduced beneficial bacteria and increased harmful taxa. With rising prevalence in developing countries like India, effective and accessible treatments remain a critical need. This multi-center randomized factorial double blind placebo controlled treat through trial will utilize a 2x 2 factorial design to randomize patients of mild to moderate (modified Mayo score 3-6) endoscopically active (Mayo endoscopic score: \>1) treatment naรƒive UC in 1:1:1:1 ratio to fecal microbiot

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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.
๐Ÿ’Š

What it tests

  • Sham transplantation
  • Anti inflammatory diet
  • Fecal Microbial Transplantation
  • Sham diet
๐Ÿ“

Where

6 sites
Department of Gastroenterology, Lisie Hospital
Kochi, India
Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion
Mumbai, India
Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences
New Delhi, India
Department of Gastroenterology, Dayanand Medical College
Ludhiana, India
Department of Gastroentrology, Postgraduate Institute of Medical Education and Research
Chandigarh, India
Department of Gastroenterology, Institute of Medical Sciences, Banaras Hindu University
Varanasi, India
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy