drugset / Trial / NCT04968951

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

NCT04968951

Phase 0 Terminated 4 enrolled Ari M Grinspan
RandomizedParallel-groupTriple-blindTreatment

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).

Timeline

Start
2021-11-10
Primary completion
2022-08-22
Completion
2022-08-22

Drugs

EvaluationDrugModalityDoseRoute
Comparator Metronidazole Small molecule 250 mg
Comparator Ornidazole Other / unclassified 15 unknown Oral
Comparator Vancomycin Other / unclassified 125 mg

Indications