RecruitingPhase 2NCT04939051

Obeticholic Acid for Prevention in Barrett's Esophagus


Sponsor

National Cancer Institute (NCI)

Enrollment

30 participants

Start Date

Jan 3, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether a drug called obeticholic acid can prevent Barrett's esophagus — a precancerous condition in the esophagus caused by acid reflux — from progressing toward cancer. **You may be eligible if...** - You have been diagnosed with Barrett's esophagus (confirmed by biopsy) with no dysplasia, low-grade dysplasia, or results that are uncertain (indefinite for dysplasia) - Your Barrett's esophagus affects at least 2 cm of the esophagus - You are currently taking proton pump inhibitor (acid-reducing) medication for at least 28 days - You are 18 or older and in reasonably good health **You may NOT be eligible if...** - Your Barrett's esophagus has already progressed to high-grade dysplasia or cancer - You are not taking acid-reducing medication - You are pregnant or breastfeeding - You have significant liver disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREBiospecimen Collection

Undergo blood sample collection

PROCEDUREEsophageal Biopsy

Undergo esophageal biopsy, brushings and gastric aspirate

PROCEDUREEsophagogastroduodenoscopy

Undergo EGD

PROCEDURELiver Ultrasonographic Elastography

Undergo liver ultrasound with elastography

BIOLOGICALObeticholic Acid

Given PO

DRUGPlacebo Administration

Given PO

OTHERQuestionnaire Administration

Ancillary study


Locations(8)

University of Kansas Cancer Center

Kansas City, Kansas, United States

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, United States

Washington University School of Medicine

St Louis, Missouri, United States

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, United States

Case Western Reserve University

Cleveland, Ohio, United States

Seidman Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

View Full Details on ClinicalTrials.gov

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NCT04939051


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