Endoscopic Sleeve Gastroplasty for Obesity and Microbiota Randomized Trial
Launched by FONDAZIONE POLICLINICO UNIVERSITARIO AGOSTINO GEMELLI IRCCS · Dec 13, 2019
Trial Information
Current as of July 09, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is investigating a procedure called Endoscopic Sleeve Gastroplasty (ESG), which aims to help people with obesity lose weight and improve their overall health. The trial will compare the effects of this procedure to standard medical treatments for obesity over a period of 36 months. Researchers want to see how ESG impacts weight loss, health factors like cholesterol and blood sugar levels, quality of life, and changes in gut bacteria, which can affect digestion and appetite.
To participate in this trial, individuals need to be between the ages of 20 and 65, have a body mass index (BMI) between 30 and 45, and be willing to follow the study guidelines. Some people may not qualify if they have certain health issues, like active stomach ulcers or a history of specific surgeries. Those who participate can expect regular follow-ups and assessments to monitor their progress and health outcomes throughout the study. Additionally, if participants in the standard treatment group do not see adequate weight loss after six months, they will have the chance to receive the ESG procedure.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- The participants have to fulfill the following criteria for participating in the study:
- • 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 Criteria:
- • Active gastric ulcer during the last 6 months
- • Organic or motility disorder of the stomach and / or esophagus
- • Anticoagulant treatment
- • Previous bariatric surgery or any other type of surgery of the esophagus, stomach and duodenum
- • 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
- • Drug or alcohol abuse
- • Bulimic or binge eating pattern
- • Continuous glucocorticoid or anti-inflammatory treatment
- • Uncontrolled thyroid disease
- • Pregnancy, breastfeeding
- • Psychiatric or cooperative problems or low compliance that is a contraindication from participating in the study
- • Hiatal hernia \> 5 cm
- • Currently participating in other study
- • Any health issue that might put the patient at risk if the treatment is performed, judged by the investigator
About Fondazione Policlinico Universitario Agostino Gemelli Irccs
Fondazione Policlinico Universitario Agostino Gemelli IRCCS is a leading research and healthcare institution based in Rome, Italy, renowned for its commitment to advancing medical science and improving patient care. As a prominent academic medical center affiliated with the Catholic University of the Sacred Heart, it integrates clinical practice, education, and research, fostering innovation in various fields of medicine. The foundation conducts a wide range of clinical trials aimed at developing new therapies and enhancing treatment protocols, with a focus on translational research that bridges the gap between laboratory discoveries and patient care. Its multidisciplinary approach and dedication to high ethical standards position it as a key player in the landscape of clinical research and healthcare improvement in Italy and beyond.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Rome, , Italy
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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