Actively Recruiting
FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis
Led by University of Aarhus · Updated on 2025-11-17
20
Participants Needed
1
Research Sites
144 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or above.
- Histologically proven diagnosis of malignant melanoma and/or kidney cancer.
- Treatment with any immune checkpoint inhibitor (Nivolumab, Pembrolizumab, Cemiplimab, Atezolizumab, Durvalumab, Avelumab, Ipilimumab), alone or in combination, within the last 8 weeks.
- Grade 2 or higher CTCAE diarrhea, with at least 3 stools scored 6-7 on the Bristol chart.
- Negative PCR test for enteric pathogens including C. difficile after diarrhea onset.
- Signed written informed consent.
You will not qualify if you...
- Diagnosed bacterial infection requiring antibiotic treatment at inclusion.
- Pregnancy or breastfeeding (ruled out by male sex, postmenopausal status, or negative hCG urine test).
- Primary diarrheal disease existing before immune checkpoint inhibitor treatment, including inflammatory bowel disease.
- Unable to swallow capsules.
- Unable to understand written or oral patient information.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
Research Team
T
Trine L Laursen, BSc
CONTACT
C
Christian L Hvas, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here