Condition: Ulcerative Colitis (UC) · Sponsor: All India Institute of Medical Sciences
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 naÃive UC in 1:1:1:1 ratio to fecal microbiota transplantation (FMT) + anti-inflammatory diet (AID) +5-aminisalicylic acid (5-ASA) (Intervention, Group A) vs fecal microbiota transplantation + sham diet +5-aminisalicylic acid(Intervention, Group B) vs sham transplantation + anti-inflammatory diet +5-aminisalicylic acid(Intervention, Group C) vs sham transplantation \+ sham diet +5-aminisalicylic acid(Control, Group D). In the induction phase patients will receive FMT/sham transplantation at 0, 2 and 6 weeks along with AID/Sham diet and 5-ASA for 10 weeks. Outcome will be assessed at 10 weeks, Treatment failure will be out of trial. Pati…
This description comes directly from the study's public registry record.
Prof Vineet Ahuja, DM Gastroenterology · +91-9810707170 · vineet.aiims@gmail.com
Dr Himanshu Narang, DM Gastroenterology · +91-8800316504 · h92narang@gmail.com
Always discuss trial participation with your own doctor first.
| 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 and Human Nutrition, All India Institute of Medical Sciences | New Delhi, National Capital Territory of Delhi, India | 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 |
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Source record: clinicaltrials.gov/study/NCT06895252