RecruitingNot ApplicableNCT06206707

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


Sponsor

University of Aarhus

Enrollment

20 participants

Start Date

Jan 23, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a fecal microbiota transplant (FMT) — transferring healthy gut bacteria from a donor — can treat severe diarrhea and bowel inflammation caused by immunotherapy drugs used to treat cancer. This side effect, called immune checkpoint inhibitor colitis, can be debilitating. **You may be eligible if...** - You are 18 or older - You have melanoma or kidney cancer treated with immune checkpoint inhibitors (such as nivolumab, pembrolizumab, or ipilimumab) - You have developed grade 2–4 diarrhea or colitis as a side effect of immunotherapy **You may NOT be eligible if...** - You have other causes of diarrhea (like infection) - You have severe immune suppression from other causes - You are on antibiotics that would interfere with the transplant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

PROCEDUREFaecal Microbiota Transplantation (FMT)

Capsule FMT

PROCEDUREPlacebo

Placebo capsules


Locations(1)

Aarhus University Hospital

Aarhus N, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06206707


Related Trials