Ursodiol in Treating Patients With Barrett Esophagus and Low-Grade Dysplasia

Exclusion Criteria

• •Barrett's esophagus with high grade dysplasia or carcinoma at enrollment
• •Medical conditions which would make completing endoscopies or completing the trial difficult including but not limited to previous transient ischemic attacks or cerebral vascular disease, severe respiratory disease, severe ischemic heart disease or myocardial infarction in the previous 6 months, inflammatory bowel disease
• •Participants may not be receiving any other investigational agents within 1 month of study enrollment
• •Have used NSAID for more than 5 days per month within 1 month of enrollment except low dose aspirin (81 mg QD)
• •History of allergic reactions attributed to compounds of similar chemical or biologic composition to UDCA
• •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
• •Pregnant and breastfeeding women are excluded from this study; breastfeeding should be discontinued during treatment; should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately
• •Have had major upper gastrointestinal (GI) surgeries within 6 months of enrollment including, but not limited to, fundoplication, bariatric surgery, cholecystectomy
• •Erosive esophagitis detected at the baseline endoscopy
• •Participants who need concurrent chemotherapy, radiotherapy, or cancer-related hormonal or immunotherapy during the time of study
• •Participants who have had chemotherapy, radiotherapy, or cancer-related hormonal or immunotherapy within 18 months of the baseline visit
• •Current or planned use of anticoagulant drugs including, but not limited to, warfarin, heparin, low molecular weight heparin, Plavix, or Aggrenox
• •Use of cyclosporine during the time of study