Obese PatientsObese Patients With Bariatric SurgeryGut MicrobiotaHealthy Participants
Study 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
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
Accepted
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).
Primary outcome measure(s)
Long-Term Changes in Gut Microbiota After Bariatric Surgery — from 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.
Trial sites (1)
Facility
City
Region
Status
Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Castellana Grotte
BA
More Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.