drugset

drugset / Trial / NCT05911997

MTC Versus FMT in for RCDI

NCT05911997 ↗

Phase 1 Recruiting 60 enrolled Icahn School of Medicine at Mount Sinai National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · collab

RandomizedParallel-groupOpen-labelPrevention

Summary

Investigating four different treatment of MTC or FMT

Timeline

Start: 2024-01-08
Primary completion: 2026-07-25
Completion: 2026-07-25

Publications

Bethlehem L, Bartu L, Marke G, Mar P, Feldman S, Eggers J, Ruprecht C, Britton GJ, Aggarwala V, Bongers G, Li Z, Yang N, Hohmann EL, Mogno I, Faith JJ, Grinspan A. 15-strain live biotherapeutic product or same donor fecal microbiota transplant for recurrent Clostridioides difficile infection: a randomized phase 1b trial. Nat Med. 2026 Jun 2. doi: 10.1038/s41591-026-04442-2. Online ahead of print.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MTC01	Other / unclassified	1e+10 cells	—
Subject	MTC01	Other / unclassified	1e+11 cells	—
Subject	Ornidazole	Other / unclassified	1e+10 cells	—
Subject	Ornidazole	Other / unclassified	1e+11 cells	—

Indications