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Life sciences · Observational Study
ClinicalTrials.gov · November 5, 2026
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Observational Study.
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Registry record from ClinicalTrials.gov (NCT07381140). This is a study registration, not published results. Lead sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 100 participants (ESTIMATED). Conditions: Obese Patients, Obese Patients With Bariatric Surgery, Gut Microbiota, Healthy Participants. Primary outcome measures: Long-Term Changes in Gut Microbiota After Bariatric Surgery , from enrollment up to 12 months of follow-up. Brief summary: The goal of this observational study is to learn how bariatric surgery affects gut bacteria and gut-related metabolic products over time in adults with obesity. The study includes adults aged 18 to 65 years who are undergoing Roux-en-Y gastric bypass (RYGB) surgery, as well as adults with obesity treated with diet alone and healthy normal-weight adults. The main questions it aims to answer are: How does bariatric surgery change the composition and diversity of gut bacteria over time? How are these changes related to weight loss and improvement of obesity-related health conditions? Researchers will compare people undergoing bariatric surgery with people with obesity treated with diet alone and with healthy normal-weight individuals to see if surgery leads to specific changes in gut bacteria and stool metabolites that are linked to better clinical outcomes. Participants will: Provide stool samples at scheduled time points over 12 months Provide blood samples and undergo routine clinical assessments Take part in follow-up visits to monitor weight, metabolic health, and gastrointestinal symptoms