Effect of proton pump inhibitors on the structural integrity of endoscopic sleeve gastroplasty: a single-centre open-label, randomized, controlled pilot clinical trial

Prior treatment

• 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
• Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum
• Drug or alcohol abuse

Other illness

• Uncontrolled thyroid disease
• Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study
• Known allergy or hypersensitivity to the active substance or any of the other excipients
• Helicobacter pylori infection
• Organic or motility disorder of the stomach and / or esophagus
• 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

Lab values

• Chronic Severe Renal Insufficiency (eGFR < 30 ml/min/1.73 m2 based on CKD-EPI equation)

Other

• Active gastric gastro-duodenal during the last 6 months
• Continuous glucocorticoid or anti-inflammatory treatment
• Pregnancy, breastfeeding
• Hiatal hernia ≥ 5 cm
• Liver cirrhosis of any Child-Phugh stage or MELD> 15
• Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.
• Anticoagulant treatment
• Bulimic or binge eating pattern

• 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