RecruitingPhase 4NCT05320796

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

The Bioavailability and Effect on Pouch pH of Esomeprazole as Tablets or in Solution After Laparoscopic Proximal RYGB for Morbid Obesity - an Investigator Blinded Pilot Study

Sponsor

Prof Urs Zingg

Enrollment

50 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

Obesity

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria4

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

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Interventions

DIAGNOSTIC_TESTupper endoscopy

A wireless BRAVO™ - pH monitoring device is placed and the participant is discharged with ongoing pH monitoring. The next day, the participant is randomized to either receive Esomeprazol MUT Sandoz® tablet 40mg or Esomeprazol MUT Sandoz® 40mg in solution. Serum concentration of Esomeprazol is measured at 0, 60 and 120 minutes and the patient is discharged after. After 48 hours of pH monitoring, the patient returns the BRAVO™ - recorder, adverse events are assessed and the study is terminated.