Tests stool transplant capsules for immune drug-related diarrhea and colitis in cancer patients
Tests stool bacteria capsules, against placebo, for diarrhea and colitis from cancer immunotherapy.
Plain-language title generated from the registry record
Registry title: FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis
Key facts
- Where
- Aarhus N, DenmarkSee the site
Where in Denmark
- Aarhus University HospitalAarhus N, DenmarkTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Aarhus
- Trial code
- NCT06206707
- Record updated
- 17 November 2025
- Original description
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.Read full original descriptionShow less
Faecal Microbiota Transplantation for Immune Checkpoint Inhibitor-mediated Diarrhea/Colitis: a Randomised, Double-blind Pilot Efficacy and Safety Study
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.
Inclusion: 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, of which at least 3 stools are Bristol chart score 6-7; Negative PCR for enteric pathogens including C. difficile, after the onset of diarrhea; Signed written informed consent.
Exclusion: Diagnosed bacterial infection requiring antibiotic treatment at inclusion; Primary diarrheal disease pre-existing to the immune checkpoint inhibitor treatment, including inflammatory bowel disease; Pregnancy or breastfeeding. Pregnancy ruled out by male sex, postmenopausal women or a negative choriogonadotropin (hCG) urine test; Unable to ingest capsules; Unable to understand written or oral patient information.