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

Recruiting now · Phase 4

Conditions studied: Obesity, Gastric Reflux, Ulcer, Gastric

In brief

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.

Key facts

Study ID

NCT05320796

Run by

Prof Urs Zingg

People needed

50

Starts

2023-11-01

Expected to finish

2027-12-31

Last updated by the study team

2026-06-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Spital Limmattal — Schlieren, Schlieren, Switzerland (enrolling)

Full record on ClinicalTrials.gov

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