Gut Microbiome and Fecal Transplant for GI Complications in Cancer Patients
This study is looking at how the bacteria in your gut (gut microbiome) might affect stomach and bowel problems (gastrointestinal or GI complications) that can happen when you're treated for cancer with immune-checkpoint inhibitor drugs. Researchers want to understand if these gut bacteria play a role in developing inflammation of the intestines (colitis). If you have melanoma or genitourinary cancer and are receiving immune-checkpoint inhibitor treatment, you might be able to join. The study involves collecting samples of your stool, blood, and tissue to learn more about how your body responds to treatment. For those who develop colitis, the study will also look at whether a fecal microbiota transplantation (FMT), which involves transferring healthy stool from a donor, can help improve symptoms like diarrhea and colitis. The main goals are to see how the gut microbiome changes and to check the safety of FMT.
- Study design
- This is an interventional study planning to enroll 800 participants. It will compare the gut microbiome in patients who develop colitis versus those who do not, and assess the safety and effectiveness of fecal microbiota transplantation (FMT).
- What's involved
- Participants will undergo collection of stool, blood, and tissue samples. Some participants may also have an endoscopy and receive infliximab or fecal microbiota transplantation (FMT).
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 1 year to measure changes in stool microbiome and the incidence of adverse events from FMT.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
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
- Difference in stool microbiome patternUp to 1 year
The primary endpoint is alpha diversity of bacteria species (measured using inverse Simpson index). It is a measure of diversity which takes into account the number of species present, as well as the relative abundance of each species. As species richness and evenness increase, so diversity increases.
- Incidence of adverse events (AE) of fecal microbiota transplantation (FMT) (Project 3)Up to 1 year
Adverse events will be recorded by Common Terminology Criteria for Adverse Events version 5 as well as FMT-specific events. All events will be recorded with grade and attribution to FMT. Adverse events that are related to fecal microbiota transplantation will be summarized using frequency and percentage by AE grade, type and attributions.