Obeticholic Acid for Prevention in Barrett's Esophagus
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNational Cancer Institute (NCI)
About this trial
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 criteria
Qualifiers
Known diagnosis of histologically-confirmed BE with either no dysplasia, indefinite for dysplasia, or low-grade dysplasia as defined by the presence of specialized columnar epithelium on histology and >= 2 cm of involvement on endoscopy
Adequate Barrett's mucosa, which is defined as at least one sample with >= 50% intestinal metaplasia in biopsies required to satisfy the endpoints of the study
Participants are on proton pump inhibitors (PPI) therapy for >= 28 days duration
Age >= of 18 years. Because no dosing or adverse event (AE) data are currently available on the use of OCA in participants < 18 years of age, children are excluded from this study but will be eligible for future pediatric trials, if applicable
Disqualifiers
History of prior ablative therapy such as radiofrequency ablation, cryotherapy or argon plasma coagulation (APC) in BE segment
Prior use of OCA
Prior history or presence of high-grade disease (HGD) or cancer on pre-intervention endoscopy
Cutaneous diseases manifesting with severe pruritus
Trial design
Treatments tested in this trial
- Biospecimen Collection
- Esophageal Biopsy
- Esophagogastroduodenoscopy
- Liver Ultrasonographic Elastography
- Obeticholic Acid
- Placebo Administration
- Questionnaire Administration
Treatment groups
30 Participants
are divided into 2 treatment groupsLocations
8University of Kansas Cancer Center66160, Kansas CityKansas, United States
University of Michigan Rogel Cancer Center48109, Ann ArborMichigan, United States
Washington University School of Medicine63110, St LouisMissouri, United States
UNC Lineberger Comprehensive Cancer Center27599, Chapel HillNorth Carolina, United States
Sponsors and collaborators
National Cancer Institute (NCI)
Lead sponsor
Source ClinicalTrials.gov