Effect of Proton Pump Inhibitors on Endoscopic Sleeve Gastroplasty Integrity
Effect of Proton Pump Inhibitors on the Structural Integrity of Endoscopic Sleeve Gastroplasty: a Single-centre Open-label, Randomized, Controlled Pilot Clinical Trial
This study is testing whether stopping or continuing a common stomach medication after a weight loss procedure helps obese patients have better results.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Fondazione Policlinico Universitario Agostino Gemelli IRCCS Academic / other |
| Locations | 1 site (Roma) |
| Trial ID | NCT06283381 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the impact of proton pump inhibitors (PPIs) on the structural integrity of endoscopic sleeve gastroplasty (ESG) in obese patients. Participants aged 20 to 65 with a BMI between 30 and 45 kg/m² will be randomly assigned to either discontinue PPIs after the procedure or continue with Esomeprazole for eight weeks. The primary goal is to assess how these medications affect the outcomes of ESG. The study is conducted at a single center, ensuring a controlled environment for data collection and analysis.
Who should consider this trial
Good fit: Ideal candidates are obese individuals aged 20 to 65 with a BMI between 30 and 45 kg/m² who require ESG.
Not a fit: Patients with recent gastric issues, previous bariatric surgeries, or certain medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into optimizing post-operative care for patients undergoing ESG, potentially improving their weight loss outcomes.
How similar studies have performed: While the specific effects of PPIs on ESG integrity have not been extensively studied, related research on post-operative care in bariatric procedures suggests potential benefits.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age 20 to 65 years * BMI between 30 to 45 kg/m2 * Willingness to participate in the study and ability to comply and understand the study protocol. Exclusion Criteria: * Active gastric gastro-duodenal during the last 6 months * Helicobacter pylori infection. * Organic or motility disorder of the stomach and / or esophagus * Anticoagulant treatment * Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum * Ongoing or active malignancy during the last 5 years. * Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association's classification. * Drug or alcohol abuse * Bulimic or binge eating pattern * Continuous glucocorticoid or anti-inflammatory treatment * Uncontrolled thyroid disease. * Pregnancy, breastfeeding * Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study. * Hiatal hernia ≥ 5 cm * Known allergy or hypersensitivity to the active substance or any of the other excipients * Liver cirrhosis of any Child-Phugh stage or MELD\> 15 * Chronic Severe Renal Insufficiency (eGFR \< 30 ml/min/1.73 m2 based on CKD-EPI equation) * Currently participating in other study, or previously participated in an experimental drugs trial within 30 days before or 5 half-life of the drug administered * Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.
Where this trial is running
Roma
- Fondazione Policlinico Universitario A. Gemelli IRCCS — Roma, Italy (Recruiting)
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.