NCT07381140 Bariatric Surgery and Gut Microbiota Changes Over Time
| NCT ID | NCT07381140 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis |
| Condition | Obese Patients |
| Study Type | OBSERVATIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-07-07 |
| Primary Completion | 2027-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 100 participants in total. It began in 2026-07-07 with a primary completion date of 2027-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
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).
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07381140 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Obese Patients. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07381140 currently recruiting?
Yes, NCT07381140 is actively recruiting participants. Contact the research team at domenica.mallardi@irccsdebellis.it for enrollment information.
Where is the NCT07381140 trial being conducted?
This trial is being conducted at Castellana Grotte, Italy.
Who is sponsoring the NCT07381140 clinical trial?
NCT07381140 is sponsored by Azienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis. The trial plans to enroll 100 participants.