Actively Recruiting
Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
Led by M.D. Anderson Cancer Center · Updated on 2026-03-11
800
Participants Needed
1
Research Sites
296 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 the role of the gut microbiome and effectiveness of a fecal transplant on medication-induced gastrointestinal (GI) complications in patients with melanoma or genitourinary cancer. The gut microbiome (the bacteria and microorganisms that live in the digestive system) may affect whether or not someone develops colitis (inflammation of the intestines) during cancer treatment with immune-checkpoint inhibitor drugs. Studying samples of stool, blood, and tissue from patients with melanoma or genitourinary cancer may help doctors learn more about the effects of treatment on cells, and help doctors understand how well patients respond to treatment. Treatment with fecal transplantation may help to improve diarrhea and colitis symptoms.
CONDITIONS
Official Title
Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of any stage melanoma, Non-Small Cell Lung Cancer, or genitourinary malignancies (Project 1)
- Diagnosis of any cancer type (Projects 2 and 3)
- Treatment with any immune-checkpoint inhibitor agent
- Ability to understand and willingness to sign informed consent and complete surveys
- Life expectancy greater than 4 months (Project 3)
- ICPI-related diarrhea and/or colitis of any grade with or without non-GI toxicity as toxicity group (Project 1)
- Patients with no organ toxicity as control group (Project 1)
- ICPI-related colitis and/or diarrhea grade 2 or higher receiving standard immunosuppressive treatment (Project 2)
- ICPI-related colitis and/or diarrhea grade 2 or higher without non-GI toxicity within 45 days prior to FMT (Project 3)
- ICPI-related colitis and/or diarrhea grade 2 or higher within 45 days prior to FMT with refractory or recurrent symptoms, contraindications, or steroid dependence (Project 3)
- No active concomitant GI infection at start of protocol therapy (Project 3)
- Cleared for enrollment by infectious diseases consultant or treating physician if positive infection workup (Project 3)
You will not qualify if you...
- Younger than 18 years
- History of inflammatory bowel disease or radiation enteritis/colitis with active disease at treatment start
- Pregnant or breastfeeding women
- Women of child-bearing potential with positive or refused pregnancy test unless clearly post-menopausal or documented no pregnancy
- Concurrent non-GI toxicity at time of FMT (Project 3)
- Active bacterial or fungal infection (Project 3)
- Donors at risk for monkeypox infection or exposure (Project 3)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
M D Anderson Cancer Center
Houston, Texas, United States, 77030
Actively Recruiting
Research Team
K
Krishna Rajalu, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
1
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