Actively Recruiting
Fecal Microbiota Transplantation (FMT) for Immune-Checkpoint Inhibitor Induced-Diarrhea/Colitis in Genitourinary Cancer Patients
Led by M.D. Anderson Cancer Center · Updated on 2026-03-20
40
Participants Needed
1
Research Sites
N/A
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
Researchers are evaluating how well fecal microbiota transplantation (FMT) works to treat diarrhea or colitis caused by immune-checkpoint inhibitors in patients with genitourinary and other cancers. This Phase 1 trial aims to assess the safety and effectiveness of FMT in achieving remission or clinical response of immune-related diarrhea or colitis, along with monitoring recurrence rates and changes in immune and microbiome markers. Participants first receive loperamide by mouth, followed by FMT administered via colonoscopy 4 hours later over 15-30 minutes. After treatment, patients are monitored closely with follow-up visits at 2, 4, and 8 weeks, and again at 3 months. The trial also evaluates PuraStat gel for healing mucosal ulcers and controlling bleeding if needed. During the study, participants will undergo assessments to track side effects related to FMT and measure clinical response or remission of diarrhea and colitis symptoms. Researchers collect tissue, blood, and stool samples to study immunological and microbiome changes. Safety monitoring continues up to 3 months post-treatment to observe recurrence and long-term effects, with a total participation duration of about 3 months.
CONDITIONS
Brief 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 within 45 days before treatment
- No active non-gastrointestinal toxicity
- History of steroid use allowed if last dose was more than 30 days before treatment or used for less than 7 days
- History of immunosuppressant use allowed if last dose was at least 3 months before treatment and not for immune checkpoint inhibitor-induced toxicity
- No active gastrointestinal infection as confirmed by tests or physician
- Cleared by infectious disease specialist if positive infection workup
- Ability to understand and willing to sign informed consent
- Life expectancy greater than 6 months
You will not qualify if you...
- Younger than 18 years
- Persistent gastrointestinal infection despite antibiotics
- History of inflammatory bowel disease or radiation enteritis/colitis with active disease
- Pregnant or breastfeeding women
- Positive pregnancy test or refusal to test without confirmed non-pregnant status
- Immunosuppressive treatment at onset of diarrhea/colitis
- Medical conditions posing high risk for colonoscopy
- Concurrent non-gastrointestinal toxicity at treatment time
- Donors at risk for monkeypox infection or exposure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single treatment day with follow-up visits up to 3 months
Participants receive loperamide orally, followed by fecal microbiota transplantation (FMT) via colonoscopy.
1 treatment visit and follow-up visits at 2, 4, and 8 weeks, and 3 months
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
Y
Yinghong Wang
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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