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Study identifier: NCT04939051 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

Obeticholic Acid for Prevention in Barrett's Esophagus

Condition: Barrett Esophagus · Esophageal Adenocarcinoma  ·  Sponsor: National Cancer Institute (NCI)

PhasePhase 2
Planned participants30
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersYes

About this study

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.

This description comes directly from the study's public registry record.

Talk to the study team

Contact details are listed per location below or on the registry record.

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Locations (8)

University of Kansas Cancer CenterKansas City, Kansas, United StatesRecruiting
University of Michigan Rogel Cancer CenterAnn Arbor, Michigan, United StatesRecruiting
Washington University School of MedicineSt Louis, Missouri, United StatesRecruiting
UNC Lineberger Comprehensive Cancer CenterChapel Hill, North Carolina, United StatesRecruiting
Case Western Reserve UniversityCleveland, Ohio, United StatesRecruiting
Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer CenterCleveland, Ohio, United StatesNot Yet Recruiting
University Hospitals Cleveland Medical CenterCleveland, Ohio, United StatesNot Yet Recruiting
Cleveland Clinic FoundationCleveland, Ohio, United StatesRecruiting

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Source record: clinicaltrials.gov/study/NCT04939051