Investigating Esomeprazole's Effect on Stomach Acid After Gastric Bypass
Official title: 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
Run by Spital Limmattal Schlieren · NCT05320796 · Data updated 2026-11-12
This study is testing how well a stomach acid medication called Esomeprazole works after gastric bypass surgery to see if it helps manage acid levels better.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Spital Limmattal Schlieren Academic / other |
| Locations | 1 site (Schlieren, Schlieren) |
| Status | Recruiting |
| Started | November 1, 2023 |
| Main results expected | December 31, 2027 |
| Study ends | December 31, 2027 |
| Registry record updated | June 9, 2026 |
| Trial ID | NCT05320796 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals who have had a Roux-en-Y gastric bypass at least 12 months prior and have been on proton pump inhibitors postoperatively.
✕Probably not a fit
Patients with known allergies to Esomeprazole or those who cannot undergo upper endoscopy will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study aims to evaluate how well Esomeprazole, a medication used to reduce stomach acid, is absorbed after Roux-en-Y gastric bypass surgery. Participants will undergo a routine upper endoscopy, during which a wireless pH monitoring device will be placed in their gastric pouch. Afterward, they will be randomly assigned to receive either Esomeprazole in tablet form or as a solution, and their serum concentration and gastric pH will be measured at specified intervals. The study will assess the relationship between the absorption of the medication and the acidity levels in the stomach pouch.
Why it matters
Potential benefit: If successful, this study could improve the management of gastric acid levels in patients who have undergone gastric bypass surgery.
How similar studies have gone: Previous studies have demonstrated the feasibility and safety of wireless pH monitoring systems, suggesting potential for success in this approach.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
Spital Limmattal
Schlieren, Schlieren, Switzerland Recruiting
Study contacts
- Principal investigator: Urs Zingg, Prof. — Limmattal Hospital
- Study coordinator: Urs Zingg, Prof.
- Email: Urs.Zingg@spital-limmattal.ch
- Phone: +41 44 733 21 26
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.