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Fecal Microbiota Transplant clinical trials

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NCT ID: NCT04968951 Terminated - Ulcerative Colitis Clinical Trials

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

REFOCUS
Start date: November 10, 2021
Phase: Early Phase 1
Study type: Interventional

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).