NCT04038619

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

Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea/Colitis in Genitourinary Cancer Patients

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Colitis
• Diarrhea
• Malignant Genitourinary System Neoplasm
• Melanoma
• Lung Cancer
• Ovarian Cancer
• Uterine Cancer
• Breast Cancer
• Cervical Cancer

Interventions

Type	Name	Description
PROCEDURE	Fecal Microbiota Transplantation	Undergo FMT via colonoscopy
DRUG	Loperamide	Given PO

Timeline

• Start date: 2021-02-01
• Primary completion: 2027-12-31
• Completion: 2027-12-31
• First posted: 2019-07-31
• Last updated: 2026-03-20

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study