Study of Faecal Microbiota Transplantation FMT Capsules for Treating Diarrhea and Colitis Caused by Immune Checkpoint Inhibitors in Patients with Melanoma or Kidney Cancer

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.

FMT in Checkpoint Inhibitor-mediated Diarrhea and Colitis