Study of Gut Microbiome and Fecal Transplant for Treating Immune-Checkpoint Inhibitor Related Gastrointestinal Problems in Adults with Melanoma, Lung, or Genitourinary Cancer

What this Trial Is About

Researchers are studying how the gut microbiome affects medication-induced gastrointestinal GI complications, such as colitis, in patients with melanoma or genitourinary cancers receiving immune-checkpoint inhibitor ICPI treatments. This trial aims to compare stool microbiome patterns in patients who develop ICPI-related colitis with those who do not, and to assess the safety, tolerability, and effectiveness of fecal microbiota transplantation FMT in managing these GI side effects. The study also explores immune and genetic factors related to colitis onset and response to treatment. Participants are involved in three main projects Project 1 includes standard care with stool and blood sample collection Project 2 involves standard treatments like prednisone, infliximab, or vedolizumab with endoscopy and sample collection before and after treatment Project 3 consists of undergoing fecal microbiota transplantation. After completing these interventions, participants are followed periodically. During the study, participants provide stool, blood, and tissue samples at various times to analyze microbiome patterns, immune profiles, and genetic factors. Endoscopies are performed to evaluate colitis features before and after treatments. Patient-reported outcomes on symptoms and quality of life are collected to measure the impact of FMT. Safety is monitored through adverse event tracking during the one-year study period, with the overall goal of understanding treatment responses and improving supportive care in cancer patients experiencing GI complications from ICPI therapy.

Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer