Actively Recruiting
Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea/Colitis: a Randomised, Double-blind Pilot Efficacy and Safety Study
Led by University of Aarhus · Updated on 2025-11-17
20
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating faecal microbiota transplantation (FMT) as a treatment for patients experiencing diarrhea or colitis caused by immune checkpoint inhibitors (IMC). This randomized, placebo-controlled trial aims to assess whether FMT is feasible, safe, and effective in promoting remission of IMC symptoms. The study focuses on patients with malignant melanoma or kidney cancer who have developed grade 2 or higher diarrhea after immune checkpoint inhibitor therapy. Participants will receive two doses of either capsule FMT or placebo capsules spaced 3 to 7 days apart. This intervention is given in addition to the patients' standard care for IMC. The trial compares outcomes between the FMT group and the placebo group to evaluate the potential benefits and safety of FMT in managing IMC. During the study, researchers will monitor clinical remission of diarrhea and colitis 42 days after treatment, along with various secondary outcomes such as therapy response, days until diarrhea resolution, microbiome changes, immunological parameters, hospitalizations, and quality of life. Assessments include clinical evaluations, laboratory tests, and patient questionnaires over a follow-up period of up to 12 weeks. Participants’ safety and treatment effects will be closely observed throughout the trial duration.
CONDITIONS
Brief 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 within the last 8 weeks
- Grade 2 or higher diarrhea with at least 3 stools Bristol chart score 6-7
- 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 urine hCG test)
- Pre-existing primary diarrheal disease 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 7 days
Participants receive two applications of either capsule FMT or placebo capsules with 3 to 7 days between applications.
2 visits for capsule applications
Duration - Up to 12 weeks after treatment
Participants are monitored for clinical remission, safety, microbiome composition, and other health outcomes up to 12 weeks after treatment.
Multiple visits over 12 weeks for assessments
Trial Site Locations
Total: 1 location
1
Aarhus University Hospital
Aarhus N, Denmark, 8200
Actively Recruiting
Research Team
T
Trine L Laursen, BSc
C
Christian L Hvas, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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