ESOMEPRAZOLE for Obesity

Inclusion criteria

• {"criterion_text":"- Age 20 to 65 years\n- BMI between 30 to 45 kg/m2\n- Willingness to participate in the study and ability to comply and understand the study protocol"}

Exclusion criteria

• {"criterion_text":"- Active gastric gastro-duodenal during the last 6 months\n- Continuous glucocorticoid or anti-inflammatory treatment\n- Uncontrolled thyroid disease\n- Pregnancy, breastfeeding\n- Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study\n- Hiatal hernia ≥ 5 cm\n- Known allergy or hypersensitivity to the active substance or any of the other excipients\n- Liver cirrhosis of any Child-Phugh stage or MELD> 15\n- Chronic Severe Renal Insufficiency (eGFR < 30 ml/min/1.73 m2 based on CKD-EPI equation)\n- 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\n- Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator.\n- Helicobacter pylori infection\n- Organic or motility disorder of the stomach and / or esophagus\n- Anticoagulant treatment\n- Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum\n- Ongoing or active malignancy during the last 5 years\n- Myocardial infarction during the past 6 months or/and heart failure class III or IV according to the New York Heart association’s classification\n- Drug or alcohol abuse\n- Bulimic or binge eating pattern"}

Primary endpoints

• {"endpoint_text":"- the assess the effect of PPIs on the proportion of patients with “Intact ESG”, “open ESG” and “partially intact ESG” at 6 months of follow-up","definition_or_measurement_approach":"Assessment of the proportion of patients classified as “Intact ESG”, “open ESG” and “partially intact ESG” at 6 months of follow-up (proportion-based endpoint at 6 months)."}

Secondary endpoints

• {"endpoint_text":"- to assess the effect of PPI on the proportion of patients with “intact ESG”, “partially intact ESG” and “open ESG”, separately, at 12 months of follow-up.","definition_or_measurement_approach":"Assessment of the proportion of patients in each category (“intact ESG”, “partially intact ESG”, “open ESG”) at 12 months of follow-up (proportion-based endpoint at 12 months)."}

Italy

Earliest CTIS Part Ii Submission Date

30-08-2024

Latest Decision Or Authorization Date

02-12-2024

Processing Time Days

94

Number Of Sites

1

Number Of Participants

40

Primary sponsor

Full Name

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Italy