Investigating Esomeprazole's Effect on Stomach Acid 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
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 |
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Spital Limmattal Schlieren Academic / other |
| Locations | 1 site (Schlieren) |
| Trial ID | NCT05320796 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with known allergies to Esomeprazole or those who cannot undergo upper endoscopy will not benefit from this study.
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 performed: Previous studies have demonstrated the feasibility and safety of wireless pH monitoring systems, suggesting potential for success in this approach.
Eligibility criteria
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 this trial is running
Schlieren
- Spital Limmattal — 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.