Evaluation of Esomeprazole on Structural Integrity Post-Endoscopic Sleeve Gastroplasty in Obesity: A Randomized Controlled Pilot Study

The primary objective of this clinical trial is to evaluate the effect of **proton pump inhibitors** (PPIs), specifically **esomeprazole**, on the structural integrity of endoscopic sleeve gastroplasty (ESG) in patients with **obesity**. This is clinically relevant as maintaining the structural integrity of ESG is crucial for its effectiveness in weight management and reducing obesity-related complications.

Secondary objectives include assessing the effects of ESG on weight loss, quality of life, metabolic risk factors, anthropometry, and satiety. These factors are important for understanding the broader impact of ESG on patient health and well-being beyond structural outcomes.

The clinical trial involves a study population comprising both **male** and **female** participants aged between 20 to 65 years, with a **Body Mass Index (BMI)** ranging from 30 to 45 kg/m². The trial focuses on individuals diagnosed with **obesity**. Participants were selected based on their willingness to participate and their ability to comply with and understand the study protocol. The trial does not include a vulnerable population. The sponsor has not provided information regarding the total number of participants. Lifestyle considerations such as diet, physical activity, or habits have not been specified in the available data.

The clinical trial is designed to evaluate the effect of **proton pump inhibitors** (PPIs) on the structural integrity of endoscopic sleeve gastroplasty (ESG) in patients with **obesity**. This study is a single-centre, open-label, randomized, controlled pilot trial. The trial will involve the administration of **esomeprazole** in two forms: solution for injection/infusion and gastro-resistant tablets, with a maximum daily dose of 80 mg. The trial is expected to run until December 31, 2025, with recruitment having commenced on June 30, 2023.

Participants will be involved in the study for a maximum treatment period of 8 weeks. The trial includes several key visits: an initial screening visit to confirm eligibility based on criteria such as age (20 to 65 years) and body mass index (BMI) between 30 to 45 kg/m², followed by regular follow-up visits at 6 and 12 months to assess the primary and secondary endpoints. The primary endpoint is to assess the effect of PPIs on the proportion of patients with "intact ESG," "open ESG," and "partially intact ESG" at 6 months. The secondary endpoint will evaluate these effects separately at 12 months.

Participants may be withdrawn from the study if they are unable to comply with the study protocol or if any adverse events occur that necessitate discontinuation. The study is not classified as a low-intervention trial and is categorized as a phase IV study. The trial's design ensures that the data collected will provide valuable insights into the impact of PPIs on ESG, contributing to the understanding of treatment options for obesity.

The clinical trial involves the administration of **Esomeprazole** in two pharmaceutical forms. The first form is a **solution for injection/infusion**, which is administered via **intravenous infusion**. The maximum daily dose for this form is 80 mg, with a total maximum dose of 80 mg over the treatment period. The treatment period is limited to a maximum of 8 days. This form of **Esomeprazole** is a chemical substance and is classified under acid pump inhibitors. The administration schedule is designed to ensure optimal therapeutic levels are maintained throughout the treatment period.

The second form of **Esomeprazole** is a **gastro-resistant tablet**, administered **orally**. Similar to the intravenous form, the maximum daily dose is 80 mg, with a total maximum dose of 80 mg over the treatment period, which also spans up to 8 days. This oral form is also a chemical substance and falls under the category of acid pump inhibitors. The gastro-resistant formulation is designed to ensure the active substance is released in the intestine, thereby enhancing its efficacy and minimizing gastric irritation.

Both forms of **Esomeprazole** are utilized as part of the experimental treatment in this trial, with no additional non-experimental treatments such as placebo or comparator treatments being employed. Participant compliance with the dosing schedule is monitored to ensure adherence to the protocol and to evaluate the effect of proton pump inhibitors on the structural integrity of endoscopic sleeve gastroplasty. The trial is conducted under controlled conditions to maintain the integrity and reliability of the data collected.

Efficacy in this clinical trial will be assessed by evaluating the effect of proton pump inhibitors (PPIs) on the structural integrity of endoscopic sleeve gastroplasty (ESG). The primary endpoint involves assessing the proportion of patients with "intact ESG," "open ESG," and "partially intact ESG" at 6 months of follow-up. Secondary endpoints will further evaluate these proportions at 12 months of follow-up. The trial will utilize a randomized, controlled design to ensure robust data collection and analysis. The efficacy parameters will be measured at specified timepoints, namely at 6 and 12 months, to determine the impact of PPIs on the structural outcomes of ESG. The trial is designed to provide insights into the long-term effects of PPIs on ESG integrity, contributing valuable data to the field of gastroenterology.