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

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.

Trial Details

NCT ID
NCT04038619
Phase
PHASE1
Sponsor
M.D. Anderson Cancer Center
Status
RECRUITING
Cancer Type
Ovarian Cancer
Interventions
  • Fecal Microbiota Transplantation
  • Loperamide
Locations (sample)
  • Houston, Texas, United States|29.76328,-95.36327

Key Eligibility Criteria

  • Diagnosis of any type of genitourinary (kidney, bladder and prostate), melanoma, non-melanoma skin cancer, lung, head \& neck, sarcoma/lymphoma, ga…
  • Treatment with any ICPI agent(s)
  • Participants with new onset of ≥ grade 2 ICPI-induced diarrhea and/or colitis symptoms based on the Common Terminology Criteria for Adverse Events …
  • Participants with a history of steroid use before FMT can be allowed if last dose was \> 30 days prior to FMT treatment or treatment duration was f…

For full eligibility, visit ClinicalTrials.gov.

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