Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients
NCT04038619 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 40
Last updated 2026-03-20
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.
Conditions
- Colitis
- Diarrhea
- Malignant Genitourinary System Neoplasm
- Melanoma
- Lung Cancer
- Ovarian Cancer
- Uterine Cancer
- Breast Cancer
- Cervical Cancer
Interventions
- PROCEDURE
-
Fecal Microbiota Transplantation
Undergo FMT via colonoscopy
- DRUG
-
Loperamide
Given PO
Sponsors & Collaborators
-
National Cancer Institute (NCI)
collaborator NIH -
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Yinghong Wang · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-02-01
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
- FDA Drug
- Yes
Countries
- United States
Study Locations
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