FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis

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-trea

Trial Details

NCT ID
NCT06206707
Phase
NA
Sponsor
University of Aarhus
Status
RECRUITING
Cancer Type
Mucosal Melanoma Melanoma
Interventions
  • Faecal Microbiota Transplantation (FMT)
  • Placebo
Locations (sample)
  • Aarhus N, Denmark|56.20367,10.17317

Key Eligibility Criteria

  • 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 …
  • Grade 2 or higher CTCAE diarrhea, of which at least 3 stools are Bristol chart score 6-7.

For full eligibility, visit ClinicalTrials.gov.

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