Actively Recruiting
Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients
Led by M.D. Anderson Cancer Center · Updated on 2026-03-20
40
Participants Needed
1
Research Sites
360 weeks
Total Duration
On this page
Sponsors
M
M.D. Anderson Cancer Center
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Fecal Microbiota Transplantation in Treating Immune-Checkpoint Inhibitor Induced-Diarrhea or Colitis in Genitourinary Cancer Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of genitourinary, melanoma, non-melanoma skin, lung, head & neck, sarcoma/lymphoma, gastrointestinal, gynecologic, or breast cancer
- Treatment with any immune-checkpoint inhibitor agent(s)
- New onset of grade 2 or higher immune-checkpoint inhibitor-induced diarrhea or colitis symptoms within 45 days prior to FMT
- Steroid use allowed if last dose was more than 30 days before FMT or lasted less than 7 days ending more than a week before FMT
- Immunosuppressant use allowed if last dose was at least 3 months before FMT when used for conditions other than immune-checkpoint inhibitor-induced GI toxicities
- No active gastrointestinal infection at start of treatment confirmed by stool tests or physician assessment
- Clearance by Infectious Diseases consultant or treating physician if infection workup was positive but no active infection present
- Ability to understand and willingness to sign informed consent
- Life expectancy greater than 6 months
You will not qualify if you...
- Younger than 18 years old
- Persistent gastrointestinal infection despite completing 5 days of antibiotics before treatment
- History of inflammatory bowel disease or radiation enteritis/colitis with active disease at treatment start
- Pregnant or breastfeeding women
- Positive pregnancy test or refusal to test unless last menstrual cycle was over 1 year ago or evidence of no pregnancy within 30 days prior to treatment
- Immunosuppressive treatment at onset of immune-checkpoint inhibitor-induced diarrhea or colitis
- Medical conditions posing high risk for colonoscopy as assessed by investigators
- Concurrent non-gastrointestinal toxicity at time of study treatment
- Donors at risk for monkeypox infection or exposure
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
Y
Yinghong Wang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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