Study Details

Open

Obeticholic Acid for Prevention in Barrett's Esophagus

People with Barrett's esophagus are at higher than average risk of developing esophageal cancer. Obeticholic Acid (OCA) is a medication similar to bile acids (a fluid made and released by the liver). OCA binds to a group of cells in the intestine that is believed to have a positive effect on preventing cancer development. The purpose of this study is to compare the safety and effects of OCA with that of a placebo on the risk of developing esophageal cancer in people with Barrett's esophagus.

Age & Gender

18 years ~ 99 years
Male, Female, Gender Inclusive

Visit Availability

Standard business hours (M-F, 8-5)

Location

North Carolina (Statewide)

What will be asked of you

The study lasts about 6 months. Half of the study participants will be asked to take obeticholic acid (OCA) pills every day. The first study visit is during a regular endoscopy that is part of usual medical care. During the endoscopy, small biopsies of the esophagus and a sample of stomach fluid will be collected. The study also includes blood draws from the arm and questionnaires. Study staff will make phone calls to check in with participants every 3-4 weeks. The last study visit after 6 months will also include an endoscopy. Biopsies, stomach fluid and blood samples will be collected again at this time.

Incentives

Information provided upon request

In-person visits:
Up to 10

Phone or online visits:
Up to 10

Total length of participation:
6 months

Looking for Specific Volunteers

Able to participate:

You have Barrett's Esophagus
You are taking Proton Pump Inhibitors (Omeprazole, Pantoprazole etc.)
You are 18 years of age or older
You are willing to test for Hep B, Hep C and HIV
You are willing to moderate alcohol intake and adhere to the specified prohibitions and restrictions

Not eligible if:

You have a history of prior esophageal treatment for Barrett's Esophagus (i.e. RFA, cryotherapy, APC)
You are pregnant, breastfeeding, or planning to become pregnant
You have a chronic liver disease
You have a history of pancreatitis or pancreatic abnormalities
You are participating in another investigational drug study

Contact the Team

Visit Location

Contact & Visit Location

Primary Contact

Visit Study Website

Primary Visit Location

Clinical and Translational Research Center (CTRC)
Burnett-Womack Building (UNC-Chapel Hill)
160 Dental Cir, Chapel Hill, NC 27514, USA

Secondary Visit Location

Clinical Research Unit
UNC Eastowne Medical Office Building
100 Eastowne Dr, Chapel Hill, NC 27514, USA

Additional Study Information

Principal Investigator

Nicholas Shaheen
Medicine-Gastroenterology

Study Type

Clinical or Medical
Interventional

Study Topics

Stomach, Digestion and Gut Health

IRB Number

22-3141

ClinicalTrials.gov

NCT04939051