Clinical trial

Bariatric Surgery and Gut Microbiota Changes Over Time

Opening soon · Not applicable · 1 countries · Registry ID NCT07381140

Opening soonNot applicableObservational

What this study is about

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

A promising-looking record is not the same as confirmed eligibility. The study team must review the full criteria and current recruitment status.

Basic eligibility

Age18 Years to 65 Years
SexAll
Healthy volunteersAccepted
ConditionObese Patients, Obese Patients With Bariatric Surgery, Gut Microbiota, Healthy Participants

Full registry criteria

Inclusion Criteria (RYGB Group): * Age between 18 and 65 years. * Adults with a body mass index (BMI) ≥ 35 kg/m² with related comorbidities, or BMI ≥ 40 kg/m², who are candidates for Roux-en-Y gastric bypass (RYGB) surgery only. Exclusion Criteria (RYGB Group): * Treatment with antibiotics within the last 3 weeks, or probiotics/prebiotics within the last 4-6 weeks, or systemic corticosteroids within the 8 weeks prior to baseline (T0). * Participation in dietary regimens or calorie restriction programs in the weeks prior to enrollment. * Chronic inflammatory bowel diseases (e.g., Crohn's disease, ulcerative colitis), ongoing enteric infections, or active neoplasms. * Previous organ transplant or ongoing systemic immunosuppressive therapy. * Pregnancy or breastfeeding. * Previous major gastrointestinal surgery. * Chronic alcohol consumption above moderate levels or substance use disorder. Inclusion Criteria (Obese Control Group): * Age between 18 and 65 years. * Adults with BMI ≥ 30 kg/m² who are candidates for structured dietary treatment. Inclusion Criteria (Healthy Control Group): * Age between 18 and 65 years. * Normal weight (BMI between 18.5 and 24.9 kg/m²). * Normal metabolic function: fasting glucose below threshold, normal ALT/AST, no diagnosis of diabetes or metabolic syndrome. * No chronic gastrointestinal diseases or conditions that could alter the gut microbiota. Exclusion Criteria (Obese Control and Healthy Control Group): * Use of antibiotics within the last 3 weeks or probiotics/prebiotics within the last 4-6 weeks. * Recent gastrointestinal surgery. * Pregnancy or breastfeeding. * Extreme diets or recent dietary changes. * Recent international travel that could have affected the gut microbiota. * Medications known to influence the gut microbiota (e.g., PPIs, metformin, steroids). * Active smoking or excessive alcohol consumption. * Significant gastrointestinal symptoms (chronic diarrhea or constipation).

Treatments and study arms

The registry does not list a named intervention.

Primary outcomes

Long-Term Changes in Gut Microbiota After Bariatric Surgeryfrom enrollment up to 12 months of follow-up

Longitudinal changes in the composition and diversity of the gut microbiota (alpha diversity, beta diversity, and relative abundance of key bacterial taxa) in patients undergoing Roux-en-Y gastric bypass (RYGB) surgery, assessed using 16S rRNA gene sequencing (short-read and full-length), compared with the Obese Control and Healthy Control groups.

Study locations

1 locations were listed when this page was built. The first 40 are shown.

Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis🇮🇹 Castellana Grotte, BA, Italy