Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer
Phase 1
800
about 4.7 years
18+
1 site in TX
What this study is about
Researchers are testing whether changes to the gut microbiome, specifically fecal transplant, can help reduce gastrointestinal (GI) problems caused by medications used to treat cancer. The trial will examine how different types of bacteria in the gut affect patients' response to treatment and their risk of developing colitis.
Simplified from trial records by PatientMatch.
What you may be asked to do
- 1.Best Practice
- 2.Biospecimen Collection
- 3.Laboratory Biomarker Analysis
- +3 more
Participation Burden
What's physically and logistically required of participants.
Requires travel to a study site
How treatment is administered
Everyone gets the investigational treatment.
Extracted study details
Pulled from the trial record to show what is being tested and what the study is measuring.
infliximab (Monoclonal antibody; neutralizes TNF-alpha), prednisone, vedolizumab
injection, intravenous, oral
Primary: Incidence of adverse events (AE) of fecal microbiota transplantation (FMT) (Project 3)
Secondary: Changes of ICPI-related symptoms, Changes of quality of life (QoL), Cytokine features that are associated with good response to FMT
Oncology