Major Program
Cancer Prevention Clinical Trials Network
Research Group
Gastrointestinal and Other Cancers
Sponsor
National Cancer Institute (NCI)
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT04939051
This phase II trial studies the effect of obeticholic acid in treating patients with Barrett's esophagus. Bile acids present in duodenogastroesophageal reflux contribute to neoplastic progression in Barrett's esophagus. Obeticholic acid has shown anti-cholestatic, anti-inflammatory and anti-fibrotic effects mediated by FXR activation. It down regulates bile acid availability and decreases proinflammatory cytokine production including IL-1beta and TNFalpha in human enterocytes and immune cells. This chain of events reduces the bile acid exposure in esophagus tissue thereby limiting bile acid induced damage and dysplastic progression.
Intervention
Biospecimen Collection, Esophageal Biopsy, Esophagogastroduodenoscopy, Liver Ultrasonographic Elastography, Obeticholic Acid, Placebo Administration, Questionnaire Administration
Condition
Barrett Esophagus, Esophageal Adenocarcinoma
Investigators
Prashanthi Thota, Nicholas J. Shaheen, Ajay Bansal, Dayna S. Early, Joseph E. Willis, Amitabh Chak, Dean E. Brenner