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

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PRIMARY OBJECTIVES: I. To assess the safety and tolerability of fecal microbiota transplantation (FMT). II. To assess the efficacy of FMT for clinical remission/response of immune-related diarrhea/colitis. SECONDARY OBJECTIVES: I. To measure the recurrence rate after achieving clinical remission/res...

PRIMARY OBJECTIVES: I. To assess the safety and tolerability of fecal microbiota transplantation (FMT). II. To assess the efficacy of FMT for clinical remission/response of immune-related diarrhea/colitis. SECONDARY OBJECTIVES: I. To measure the recurrence rate after achieving clinical remission/response of immune-related diarrhea/colitis. EXPLORATORY OBJECTIVES: I. To assess the efficacy of FMT to achieve endoscopic remission of immune-related diarrhea/colitis. II. To assess the efficacy of FMT to achieve histological remission of immune-related diarrhea/colitis. III. To assess the efficacy of FMT on recurrence of immune-related diarrhea/colitis after resumption of immune checkpoint inhibitors (ICPI). IV. To assess immunological, molecular and microbiome changes in tissue/blood/stool. OUTLINE: Patients receive loperamide orally (PO). After 4 hours, patients undergo FMT via colonoscopy over 15-30 minutes. After completion of study treatment, patients are followed up at 2, 4, and 8 weeks, and then at 3 months.

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