The Bioavailability and Effect on Pouch pH of Esomeprazole After Gastric Bypass
Recruiting · NCT05320796 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
upper endoscopy
What this trial is about
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 take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 4
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed.
- Spital Limmattal - Schlieren, Schlieren, Switzerland