Role of Microbiome in the Realm of Immune-Checkpoint Inhibitor Induced GI Complications In Cancer Population
M.D. Anderson Cancer Center
Summary
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.
Description
PRIMARY OBJECTIVES: I. To compare the difference in stool microbiome pattern between patients who develop immune-checkpoint inhibitor (ICPI)-related colitis and patients who don't develop ICPI-related colitis. II. To compare the difference in stool microbiome pattern in patients who developed ICPI-related colitis before and after colitis medical treatment. III. To assess the safety and tolerability and efficacy of fecal microbiota transplantation (FMT). SECONDARY OBJECTIVES: I. To identify and characterize immune profile and genetic factors associated with onset of ICPI-related colitis in…