NCT06206707

FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis

Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea/Colitis: a Randomised, Double-blind Pilot Efficacy and Safety Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: University of Aarhus · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this clinical trial is to determine the outcome of patients with immune checkpoint inhibitor-mediated diarrhea/colitis (IMC) treated with faecal microbiota transplantation (FMT) in a randomised, placebo-controlled trial. The aim of the present study is to assess the feasibility, pilot efficacy, and safety of FMT for patients with IMC. Participants will be treated two times with capsule FMT or placebo capsules in a 1:1 ratio. The intervention treatment will be an add-on to the patients' standard treatment for IMC. Researchers will compare the FMT-treated group to the placebo-treated group to see if FMT promotes remission of IMC.

Detailed description

As above

Conditions

• Diarrhea
• Colitis
• Malignant Melanoma
• Kidney Cancer

Interventions

Type	Name	Description
PROCEDURE	Faecal Microbiota Transplantation (FMT)	Capsule FMT
PROCEDURE	Placebo	Placebo capsules

Timeline

• Start date: 2024-01-23
• Primary completion: 2026-06-30
• Completion: 2026-10-31
• First posted: 2024-01-16
• Last updated: 2025-11-17

Locations

1 site across 1 country: Denmark