OncRef

Clinical Trial: NCT04038619

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

Status:

RECRUITING

Phase:

Phase 1

Lead Sponsor:M.D. Anderson Cancer Center
Information Provided By:M.D. Anderson Cancer Center
Last Update Posted:2026-09-18

Study Overview

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.

Official Title

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

Conditions

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

Intervention / Treatment

  • Procedure: Fecal Microbiota Transplantation
  • Drug: Loperamide

Other Study ID Numbers

  • 2018-0663
  • NCI-2019-02660
  • 2018-0663

Start Date (Actual)

2021-02-01

Primary Completion Date (Estimated)

2027-12-31

Study Completion Date (Estimated)

2027-12-31

Enrollment (Estimated)

40

Study Type

Interventional

Phase

Phase 1