Condition: Ulcerative Colitis · Sponsor: All India Institute of Medical Sciences
Ulcerative colitis (UC) is a chronic inflammatory disease of the colon characterized by superficial mucosal inflammation. Treatment aims to achieve and maintain remission, improve quality of life, and minimize complications. Advanced therapies, including biologics and small molecules, have significantly improved UC management by targeting specific inflammatory pathways. However, due to the multifactorial nature of UC-driven by genetic, environmental, and microbial factors-many patients do not achieve sustained remission, highlighting a therapeutic ceiling. Gut microbial dysbiosis and immune dysregulation are central to UC pathogenesis, with diet playing a critical role in influencing the gut microbiome. While biologics and small molecules have limitations, innovative approaches like combining fecal microbiota transplantation (FMT) and dietary interventions with advanced therapies show promise. FMT restores microbial balance, modulates immunity, and reduces inflammation, while dietary modifications, such as anti-inflammatory diets, enhance FMT efficacy by creating a favorable environment for donor microbiota engraftment. The present study is designed to evaluate the efficacy of three different microbiome manipulation strategies- FMT, AID and FMT + AID in combination with advanced therapies in patients with active UC in a 2X2 factorial trial design. Patients would be randomized into four different arms: FMT, AID, FMT+AID and placebo. The advanced therapies (biologics or small m…
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 Gasteroentrology · +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 | Varanasi, Uttar Pradesh, India | Not Yet Recruiting |
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Source record: clinicaltrials.gov/study/NCT06906445