NCT05911997

MTC Versus FMT in for RCDI

Comparison of MTC01 vs FMT for the Treatment of Recurrent Clostridioides Difficile Infection

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Investigating four different treatment of MTC or FMT

Detailed description

The purpose of this research study is to compare two different treatments for patients with recurrent Clostridiodies difficile infections: MTC01 vs fecal microbiota transplantation (FMT). FMT is the transfer of bacteria from a healthy donor's colon to a recipient's colon. To do this, stool from a healthy donor is blended with salt water and made into a liquid solution rich in bacteria. This solution is sprayed into the recipient's colon during a colonoscopy. This treatment is now considered standard medical care for recurrent Clostridioides difficile infections. One FMT dose contains the entire collection of microbes in a healthy donor and is made up of billions of microbes. Each dose of FMT is different from the next and it is unknown exactly what microbes are present in each dose.

Conditions

• Clostridiodies Difficile Infections

Interventions

Type	Name	Description
DRUG	MTC 01	Slurry to be administered via colonoscopy
DRUG	Fecal Microbiota Transplantation (FMT)	Stool from a healthy donor is blended with salt water and made into a liquid solution rich in bacteria. This solution is sprayed into the recipient's colon during a colonoscopy

Timeline

• Start date: 2024-01-08
• Primary completion: 2026-07-25
• Completion: 2026-07-25
• First posted: 2023-06-22
• Last updated: 2025-11-10

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study