Obeticholic Acid for Prevention in Barrett's Esophagus

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.

Conditions

• Barrett Esophagus
• Esophageal Adenocarcinoma

Interventions

PROCEDURE

Biospecimen Collection

Undergo blood sample collection

PROCEDURE

Esophageal Biopsy

Undergo esophageal biopsy, brushings and gastric aspirate

PROCEDURE

Esophagogastroduodenoscopy

Undergo EGD

PROCEDURE

Liver Ultrasonographic Elastography

Undergo liver ultrasound with elastography

BIOLOGICAL

Obeticholic Acid

Given PO

DRUG

Placebo Administration

Given PO

OTHER

Questionnaire Administration

Ancillary study

Sponsors & Collaborators

• National Cancer Institute (NCI)

  lead NIH

Principal Investigators

• Prashanthi Thota · University of Michigan Rogel Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-01-03

Primary Completion

2027-09-01

Completion

2027-09-01

FDA Drug

Yes

Countries

• United States

Study Locations