Clinical Research Directory
Browse clinical research sites, groups, and studies.
FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis
Sponsor: University of Aarhus
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.
Official title: Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea/Colitis: a Randomised, Double-blind Pilot Efficacy and Safety Study
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
20
Start Date
2024-01-23
Completion Date
2026-10-31
Last Updated
2025-11-17
Healthy Volunteers
No
Interventions
Faecal Microbiota Transplantation (FMT)
Capsule FMT
Placebo
Placebo capsules
Locations (1)
Aarhus University Hospital
Aarhus N, Denmark