RecruitingPhase 1NCT04038619

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


Sponsor

M.D. Anderson Cancer Center

Enrollment

40 participants

Start Date

Feb 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study investigates whether transplanting healthy gut bacteria from a donor (called fecal microbiota transplant or FMT) can help patients whose immune systems have been severely damaged by immunotherapy (checkpoint inhibitor) drugs used to treat cancer. These immune-related side effects can be life-threatening. **You may be eligible if...** - You received immunotherapy (immune checkpoint inhibitor drugs) for cancer - You developed serious immune-related side effects, such as severe colitis (gut inflammation), that are not responding to steroid treatment - You are 18 or older **You may NOT be eligible if...** - You have active infections that could be worsened by the procedure - You are severely immunocompromised beyond what is expected from your treatment - You have certain bowel conditions that make the procedure unsafe Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFecal Microbiota Transplantation

Undergo FMT via colonoscopy

DRUGLoperamide

Given PO


Locations(1)

M D Anderson Cancer Center

Houston, Texas, United States

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NCT04038619


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