RecruitingPhase 4NCT06283381

The ESG Integrity Study: Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty

Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty: a Single-centre Open-label, Randomized, Controlled Pilot Clinical Trial


Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Enrollment

40 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The study is a single center randomized, open-label, phase IV clinical trial. Obese patients who have indication to Endoscopic sleeve gastroplasty (ESG) for clinical reasons are included and ESG is performed as per clinical practice. After randomization, the patients are divided in two arms: * Arm A: patients will stop proton pump inhibitors (PPI) 24h after the procedure. * Arm B: patients will assume oral Esomeprazole 40 mg twice a day for 4 weeks and 40 mg once a day for 4 weeks (total 8 weeks of PPIs after ESG- standard current treatment). The primary aim of the study is to evaluate the effect of PPI on the structural integrity of the ESG


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Esomeprazole for people with obesity. The study is currently recruiting participants at 1 location.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGEsomeprazole

oral administration, tablets, 40 mg


Locations(1)

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, Italy

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NCT06283381


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