The role of Bile Acids in Gastroesophageal Reflux Disease (GERD)

• Purpose: The purpose of this study is to provide Ironwood Pharmaceuticals with a set of coded saliva, gastric aspirate, and serum samples for the analysis of bile acids in subjects with Gastroesophageal Reflux Disease. We will also analyze relevant clinical data to characterize these participants’ disease state, symptoms, and medication use. • Ultimate Intended Purpose: Ironwood is developing a bile acid sequestrant as potential add-on therapy to proton pump inhibitors for GERD. They have data from a phase II clinical trial suggesting that their compound (IW-3718) is beneficial. They are seeking more data on the concentration, characteristics, and prevalence of bile acids in gastric refluxate in order to gauge the potential utility of IW-3718. The data and specimens for up to 100 subjects with GERD will be obtained from the Gastroenterology and Hepatology Biorepository, STU00203172.