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NCT07381140
Bariatric Surgery and Gut Microbiota Changes Over Time
Conditions: Obese Patients, Obese Patients With Bariatric Surgery, Gut Microbiota, Healthy Participants
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: Yes
Enrollment: 100
Sponsor: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
Location: Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis Castellana Grotte BA
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 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).
Source: ClinicalTrials.gov (NCT07381140). StuddyBuddy aggregates publicly available trial information.