Bariatric Surgery and Gut Microbiota Changes Over Time
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorAzienda Ospedaliera Specializzata in Gastroenterologia Saverio de Bellis
About this trial
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
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Obese subjects attending the clinical nutrition outpatient clinic of the IRCCS "Saverio de Bellis" - Castellana Grotte (BA).
Trial design
Design model
Case-control
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 3 trial groupsGroup A: RYGB Group
Group B: Obese Control Group
Group C: Healthy Control Group
Trial outcomes
Primary outcomes
1
Long-Term Changes in Gut Microbiota After Bariatric Surgery
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.
Time frame
from enrollment up to 12 months of follow-upSecondary outcomes
1
Comparison of Short- and Long-Read 16S Sequencing
Compare the performance of short-read (V3-V4) and long-read (full-length 16S rRNA) sequencing technologies in terms of taxonomic resolution and biomarker identification.
Time frame
from enrollment up to 12 months of follow-up2
Fecal Metabolome Changes and Predictive Microbe-Metabolite Signatures After Bariatric Surgery
Assess changes in the fecal metabolome over time after bariatric surgery and Identify microbe-metabolite signatures predictive of clinical response to bariatric surgery.
Time frame
from enrollment up to 12 months of follow-up3
Association Between Gut Microbiota and Clinical Outcomes
Analyze the association between gut microbiota changes and clinical/metabolic parameters (weight loss, comorbidities, inflammatory and intestinal permeability markers)
Time frame
from enrollment up to 12 months of follow-upSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: