The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass (NCT05320796) | Clinical Trial Compass
RecruitingPhase 4
The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass
Switzerland50 participantsStarted 2023-11-01
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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