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RECRUITING
NCT06906445
NA

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

Sponsor: All India Institute of Medical Sciences

View on ClinicalTrials.gov

Summary

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 molecules) would be given in all four arms as standard therapy. With this design the trial would answer two important questions: a) efficacy of combination treatment with advanced therapies and microbiome manipulation strategies in active UC, and b) comparative efficacy of different microbiome manipulation strategies.

Official title: Efficacy of Microbiome Manipulation Strategies Fecal Microbial Transplant or Anti-inflammatory Diet or Both With Advanced Therapies BiOlOgics and Small Molecules to Break the Therapeutic Ceiling in Active Ulcerative Colitis BOOST-UC A Multicenter Double Blind Factorial Randomized Controlled Trial

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

220

Start Date

2025-03-15

Completion Date

2028-03-15

Last Updated

2025-04-02

Healthy Volunteers

No

Interventions

OTHER

Fecal Microbial Transplantation

This will involve colonoscopic instillation of fecal transplant

OTHER

Anti-Inflammatory Diet

The modified diet plan will be given to each study participant

OTHER

Sham transplantation

Sham FMT will involve saline infusion via colonoscopy

OTHER

Sham Diet

Dietary counselling alone

OTHER

Advanced Therapy

Advanced therapy as standard dose and schedule

Locations (6)

Department of Gastroenterology, Lisie Hospital

Kochi, Kerala, India

Lokmanya Tilak Municipal General Hospital and Lokmanya Tilak Municipal Medical College, Sion

Mumbai, Maharashtra, India

Department of Gastroenterology and Human Nutrition, All India Institute of Medical Sciences

New Delhi, National Capital Territory of Delhi, India

Department of Gastroenterology, Dayanand Medical College

Ludhiana, Punjab, India

Department of Gastroentrology, Postgraduate Institute of Medical Education and Research,

Chandigarh, Punjab/Haryana, India

Department of Gastroenterology, Institute of Medical Sciences

Varanasi, Uttar Pradesh, India