NCT04883762

Stool Transplant to Control Treatment-related Diarrhea

Fecal Microbiota Transplantation (FMT) for Immune Checkpoint Inhibitor (ICI)-Related Diarrhea: A Pilot Study

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Memorial Sloan Kettering Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will test the safety, effectiveness, and feasibility of a treatment called fecal microbiota transplantation (FMT) to reduce the symptoms of ICI-related diarrhea. FMT uses a liquid preparation of stool collected from a healthy donor with normal (healthy) bacteria; this liquid is infused into the small or large intestine of a recipient during a colonoscopy procedure. The study researchers think that the healthy bacteria in the transplanted stool will grow and replace the unhealthy bacteria and return the intestines and colon of the recipient to a healthy state.

Conditions

• Fecal Microbiota Transplantation (FMT)

Interventions

Type	Name	Description
BIOLOGICAL	Fecal Microbiota Transplantation (FMT)	Undergo FMT via colonoscopy.

Timeline

• Start date: 2021-05-10
• Primary completion: 2026-05-01
• Completion: 2026-05-01
• First posted: 2021-05-12
• Last updated: 2025-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study