Spots Global Cancer Trial Database for Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients

Study Description

Brief Summary: This trial studies how well fecal microbiota transplantation works in treating diarrhea or colitis (inflammation of the intestines) that is caused by certain types of medications (called immune-checkpoint inhibitors) in patients with genitourinary cancer. Fecal microbiota transplantation may effectively reduce the incidence of immune checkpoint inhibitor-induced diarrhea/colitis.

Detailed Description: PRIMARY OBJECTIVES: * To assess the safety and tolerability of fecal microbiota transplantation (FMT). * To assess the efficacy of FMT for clinical remission/response of immune-related diarrhea/colitis. SECONDARY OBJECTIVES: - To measure the recurrence rate after achieving clinical remission/response of immune-related diarrhea/colitis. EXPLORATORY OBJECTIVES: * To assess the efficacy of FMT to achieve endoscopic remission of immune-related diarrhea/colitis. * To assess the efficacy of FMT to achieve histological remission of immune-related diarrhea/colitis. * To assess the efficacy of FMT on recurrence of immune-related diarrhea/colitis after resumption of immune checkpoint inhibitors (ICPI). * To assess immunological, molecular and microbiome changes in tissue/blood/stool. To study the efficacy and/ or benefit of PuraStat gel in the healing of mucosal ulcers and its hemostatic effect on bleeding lesions 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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

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