Effect of proton pump inhibitors on the structural integrity of endoscopic sleeve gastroplasty: a single-centre open-label, randomized, controlled pilot clinical trial
Key facts
- Where
- Rome, OlaszországSee the site
- Phase
- 4. fázis
Where in Olaszország
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRome, OlaszországTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- EU 2024-517679-18-00
- Record updated
- 2024. december 2.
- Original description
To evaluate the effect of PPI’s on the structural integrity of the ESGRead full original descriptionShow less
To evaluate the effect of PPI’s on the structural integrity of the ESG
Inclusion: 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: 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; 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; Chronic Severe Renal Insufficiency (eGFR < 30 ml/min/1.73 m2 based on CKD-EPI equation); 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.