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