Fecal Microbiota Transplantation for Diarrhea/Colitis in Cancer Patients
This study is investigating if fecal microbiota transplantation (FMT) can help treat diarrhea or colitis (inflammation of the intestines) that is caused by immune-checkpoint inhibitor medications. These medications are used to treat various cancers, including genitourinary (kidney, bladder, prostate), melanoma, lung, and others. Participants will receive loperamide by mouth, followed by FMT through a colonoscopy. Researchers want to see how safe FMT is and if it can lead to clinical improvement or remission of the diarrhea/colitis. The study plans to enroll 40 adult patients who are currently receiving immune-checkpoint inhibitor treatment.
- Study design
- This is an interventional study with a planned enrollment of 40 participants. The phase of the study is not specified.
- What's involved
- You would receive loperamide by mouth, then undergo a fecal microbiota transplantation (FMT) via colonoscopy. The colonoscopy procedure takes 15-30 minutes.
- Compensation
- Not stated in the trial record.
- Follow-up
- After the study treatment, you will have follow-up visits at 2, 4, and 8 weeks, and then at 3 months.
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Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients
At a glance
Conditions
Where it's being run
1 sites across 1 statesStudy leadership
- Yinghong Wang · PRINCIPAL_INVESTIGATOR · M.D. Anderson Cancer Center
Who to contact
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What this trial measures
- Incidence of fecal microbiota transplantation (FMT)-related adverse eventsUp to 3 months post-FMT
Assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 5. All events are recorded with grade and attribution to FMT.
- Clinical response/remission of immune-related diarrhea/colitisAt 2 weeks post-FMT
Clinical remission of immune related events defined as improvement of symptoms of grade 1 or lower within 2 weeks post-FMT. Clinical partial response of immune related diarrhea/colitis defined as improvement of diarrhea/colitis to a lower grade than the initial presentation but not meeting criteria of clinical remission at 2 week post-FMT time point.