Study of Esomeprazole Tablets vs Solution to Measure Acid Levels After Gastric Bypass Surgery

What this Trial Is About

This research aims to evaluate how esomeprazole, given either as a tablet or dissolved in water, affects acid production in the stomach pouch of patients who have undergone Roux-en-Y gastric bypass surgery for morbid obesity. The study focuses on measuring the acid level pH in the gastric pouch and the concentration of esomeprazole in the blood to understand absorption differences after this type of surgery. Participants will undergo a routine upper endoscopy about one year after their gastric bypass surgery. During this procedure, a wireless pH monitoring device is placed in the stomach pouch to continuously measure acid levels. The next day, participants are randomly assigned to receive a single dose of esomeprazole either as a tablet or as a solution dissolved in water. Blood samples are taken before and after dosing to measure esomeprazole levels, and pH monitoring continues for 48 hours. During the study, participants will be monitored for 48 hours with the wireless pH device recording stomach acidity. Blood samples will be collected at specified times to assess the drug concentration. After 48 hours, the pH device is removed, and any adverse effects are checked before the study ends. The primary measure is the pH level over 48 hours, with secondary focus on esomeprazole blood concentrations two hours after dosing. Participants typically complete the study within two days after the initial endoscopy.

The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass