About this trial
This study looks at the effects of obeticholic acid for patients with Barrett's esophagus. Barrett's esophagus is a condition where the cells in the esophagus change, which can lead to more serious problems. The goal of this trial is to see if obeticholic acid can help reduce damage in the esophagus and prevent worsening of the condition by lowering harmful bile acids and inflammation.
The trial ID is NCT04939051. It is a Phase 2 study, which means it is looking at how well the treatment works and its safety. This study is regulated by the FDA and aims to include about 30 participants.
Who can join
Adults aged 18 and older can join. This includes men and women with a diagnosis of Barrett's esophagus without high-grade dysplasia or cancer. People with certain health issues or recent cancer treatments are not eligible. The trial team will confirm who can join.
Conditions
Barrett Esophagus, Esophageal Adenocarcinoma
Age group
Adult, Older adult
The study team makes the final call on eligibility.
What happens in the study
Participants are placed into two groups by chance. One group gets obeticholic acid every day for 6 months. The other group receives a placebo, which looks like the medicine but does not contain any active ingredients. Everyone will have tests, including blood samples and esophageal examinations, throughout the study.
Where
This trial is running at 8 locations in the United States. 6 of them are currently recruiting.
Case Western Reserve University
Cleveland, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina
University of Kansas Cancer Center
Kansas City, Kansas
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan
Washington University School of Medicine
St Louis, Missouri
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Cleveland, Ohio
University Hospitals Cleveland Medical Center
Cleveland, Ohio