Overview

Refined Fecal Microbiota Transplantation (FMT) for Ulcerative Colitis (UC)

Status:
Recruiting

Trial end date:
2023-07-01

Target enrollment:
0

Participant gender:
All

Summary

The researchers intend to prospectively study the safety, clinical efficacy and microbial outcomes in patients with recently diagnosed UC with FMT capsule therapy derived from pre-defined donors. Donors will be specifically screened for Fusobacterium and Sutterella species as well as for global diversity. It is unknown if treatment with antibiotics before FMT improves the engraftment and/or efficacy of FMT in UC, therefore the researchers plan to randomize subjects to receive pre-treatment with antibiotics or not before FMT therapy. The research team enroll patients from The Susan and Leonard Feinstein IBD Center and our established early diagnosis clinic at Mount Sinai Hospital (MSH).

Phase:

Early Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Ari M Grinspan

Treatments:

Metronidazole
Vancomycin

Criteria

- Adults aged 18 to 75 with UC, with initial diagnosis of UC >3 months prior to time of
study enrollment visit

- Partial Mayo score of 4-10 with endoscopic subscore ≥2 on flexible sigmoidoscopy

- Permissible UC medications include oral or rectal administered mesalamines

- Corticosteroids must be discontinued at least 4 weeks before enrollment

- Documented negative C. difficile and GI PCR for enteric pathogens (BioFire) testing
before commencement of fecal microbiota transplantation

- Previous documentation of ulcerative colitis based on colonoscopy/flexible
sigmoidoscopy with compatible histology