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Recruiting NCT05320796

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

Conditions: Obesity, Gastric Reflux, Ulcer, Gastric

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 50
Sponsor: Prof Urs Zingg

Location: Spital Limmattal Schlieren Schlieren

Summary

The objective of this study is to investigate the effect of Esomeprazol administered in tablets (Esomeprazol MUT Sandoz® 40mg) or in solution (Esomeprazol MUT Sandoz® 40mg in 10ml tap water) on acid production in the gastric pouch by measuring the intragastric pH and the serum concentration of esomeprazole.

Eligibility Criteria

Inclusion Criteria: * Proximal Roux-en-Y gastric bypass with linear stapled anastomosis 12 months prior to the study investigation * Routine administration of proton pump inhibitors for 6 months postoperatively * No intake of proton pump inhibitors at least 4 weeks prior to study investigation * No marginal ulcers in upper endoscopy prior to placement of wireless BRAVO™ pH monitoring capsule * No symptoms related to gastro-esophageal reflux or marginal ulcers (i.e. epigastric pain, retrosternal burning, regurgitation) * Informed consent as documented by signature Exclusion Criteria: * Known intolerance or allergy for Esomeprazol * Contraindication for upper endoscopy * Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant * Women who are pregnant or breast feeding Major hepatic dysfunction

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05320796). StuddyBuddy aggregates publicly available trial information.