Study of esomeprazole effects on endoscopic sleeve gastroplasty structural integrity in obese patients

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What is this study about?

This clinical trial focuses on patients with obesity who undergo a weight loss procedure called endoscopic sleeve gastroplasty (ESG). This is a minimally invasive procedure where the stomach is made smaller using an endoscopic device, helping patients feel full with less food. The study examines how medications called proton pump inhibitors (PPIs) affect the success of this procedure.

The study uses esomeprazole, a type of PPI that reduces stomach acid production. The medication will be given in two different forms: as tablets taken by mouth and as a solution given through an intravenous line. The maximum daily dose is 80 mg, and treatment continues for up to 8 weeks.

The purpose of this study is to determine how well the stomach procedure holds up over time when patients take acid-reducing medications. The research team will monitor patients for up to one year after the procedure to check if the stomach maintains its new shape and size. This information will help doctors understand whether these medications affect the long-term success of the weight loss procedure.

1 Initial procedure

You will undergo an endoscopic sleeve gastroplasty (ESG), which is a procedure to reduce the size of your stomach

This procedure is performed for patients with a body mass index (BMI) between 30 to 45 kg/m²

2 Treatment assignment

You will be randomly assigned to receive either esomeprazole treatment or no treatment

If assigned to the treatment group, you will receive esomeprazole through two methods:

– First by intravenous infusion (directly into your vein)

– Then by oral administration (taking pills by mouth)

3 6-month follow-up

After 6 months, your stomach will be examined to check the condition of the ESG procedure

The examination will determine if the ESG is intact, partially intact, or open

4 12-month follow-up

A final examination will be conducted at 12 months

This examination will again assess the condition of your ESG procedure

The study will evaluate how the medication affected the long-term results of your procedure

5 Study completion

The study is expected to continue until December 31, 2025

Your participation will help determine if stomach acid-reducing medication (proton pump inhibitors) affects the success of the ESG procedure

Who Can Join the Study?

You must be between 20 and 65 years old
Your Body Mass Index (BMI) must be between 30 and 45 (BMI is a measure of body fat based on height and weight)
You must be willing to participate and understand all study procedures and requirements
You can be either male or female
You must be able to follow all study instructions and attend all required visits
You must be able to provide informed consent on your own

Who Cannot Join the Study?

Age below 18 or above 65 years old
Pregnancy or breastfeeding
Active gastric ulcers (open sores in the stomach lining)
Previous stomach or weight loss surgery
Uncontrolled diabetes (high blood sugar levels)
Severe heart or lung diseases
Blood clotting disorders or current use of blood thinners
Active substance abuse or addiction
Body Mass Index (BMI) below 30 or above 40 (BMI is a measure of body fat based on height and weight)
Ongoing treatment with medications that could affect stomach acid production
History of gastrointestinal bleeding (bleeding in the digestive system)
Current participation in other clinical trials
Known allergies to medications used in the study
Inability to follow study procedures or attend follow-up visits
Serious mental health conditions that could affect participation

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Italy	Recruiting	30.06.2023

Trial locations

Investigated drugs:

Esomeprazole

Proton pump inhibitors (PPIs) are medications that reduce stomach acid production. They work by blocking the enzyme in the stomach wall that produces acid. These medications are commonly used to treat conditions like acid reflux, heartburn, and stomach ulcers. In this trial, they are being studied to understand how they affect the results of endoscopic sleeve gastroplasty (a weight-loss procedure).

Endoscopic sleeve gastroplasty (ESG) is not a medication but a minimally invasive weight-loss procedure where the stomach is reduced in size using endoscopic suturing. This procedure helps patients feel full with smaller portions of food. The trial examines how the use of PPIs might impact the durability and effectiveness of these sutures.

Investigated diseases:

Obesity

Obesity – A chronic medical condition characterized by excessive accumulation of body fat that may impair health. The condition develops when caloric intake consistently exceeds energy expenditure over an extended period. Body fat accumulates gradually, affecting various body systems and functions. The condition can be influenced by genetic factors, lifestyle choices, and environmental conditions. Obesity is typically measured using Body Mass Index (BMI), with a BMI of 30 or higher indicating obesity.

Trial ID:

2024-517679-18-00

Protocol code:

E S G I S

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study of esomeprazole effects on endoscopic sleeve gastroplasty structural integrity in obese patients

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?