Fecal Microbiota Transplantation Treatment for Immune-Checkpoint Inhibitor Caused Diarrhea or Colitis in Patients with Genitourinary and Other Cancers

What this Trial Is About

Researchers are studying how fecal microbiota transplantation FMT may help treat diarrhea or colitis caused by immune-checkpoint inhibitors in patients with genitourinary and other cancers. The trial focuses on assessing the safety and effectiveness of FMT in reducing symptoms related to these immune-related intestinal conditions. This phase 1 study also explores the healing effects of PuraStat gel on mucosal ulcers and bleeding lesions. Participants receive loperamide orally, and after 4 hours, they undergo FMT via colonoscopy, which takes about 15 to 30 minutes. Following the treatment, patients are monitored through follow-up visits at 2, 4, and 8 weeks, and then again at 3 months. The study evaluates safety, clinical response, recurrence rates, and tissue and microbiome changes. During the study, participants will have assessments to monitor adverse events and response to treatment, including clinical, endoscopic, and histological evaluations when possible. Researchers will also study immunological, molecular, and microbiome changes using tissue, blood, and stool samples. The total follow-up duration extends up to three months after FMT to track safety and effectiveness outcomes.

Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients