drugset

drugset / Trial / NCT05911997

MTC Versus FMT in for RCDI

NCT05911997 ↗

Phase 1 Completed 38 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: 2025-11-13
Completion: 2025-12-03

Outcome

Met primary endpoint

paper The primary outcome of safety was met with 10 adverse events across eight patients PMID 42230754 ↗

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 Jul;32(7):2546-2555. doi: 10.1038/s41591-026-04442-2. Epub 2026 Jun 2.

Drugs

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

Indications