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Completed
NCT07051824
Probiotic and Prebiotic Use in Early Postoperative Period of Sleeve Gastrectomy
Conditions: Sleeve Gastrectomy, Gastrointestinal Symptoms, Prebiotic, Probiotic
Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Ayten Altunsaray
Location: Türk Obezite Cerrahisi Vakfı Ankara Çankaya
Summary
This randomized controlled clinical study investigates the effects of daily synbiotic supplementation (containing Lactobacillus rhamnosus GG and partially hydrolyzed guar gum) in patients who underwent sleeve gastrectomy. 60 participants aged 18-65 with a BMI of 35 or higher were randomly assigned to intervention (n=30) and control (n=30) groups. The intervention group received a 5 g sachet daily for 12 weeks postoperatively, mixed into 200 ml of yogurt and consumed during afternoon snacks. The control group received no supplementation. Anthropometric measurements, biochemical parameters, and gastrointestinal outcomes were assessed at baseline, week 4, and week 12. The aim is to evaluate the influence of probiotic and prebiotic supplementation on gastrointestinal function and biochemical markers in the early postoperative period following bariatric surgery.
Eligibility Criteria
Inclusion Criteria:
* Voluntary participation (provided informed consent)
* Age between 18 and 65 years
* Body mass index (BMI) ≥ 35 kg/m²
* Underwent laparoscopic sleeve gastrectomy
Exclusion Criteria:
* Use of antibiotics for more than 5 days after surgery
* Antibiotic use within 6 months prior to surgery
* Use of any prebiotic or probiotic supplement within 3 months prior to surgery
* Known intolerance to prebiotics or probiotics
* Use of immunosuppressive drugs or NSAIDs
* Diagnosed with liver or kidney failure
* Age under 18 or over 65
* History of cholecystectomy or scheduled simultaneous cholecystectomy with sleeve gastrectomy
* Lactose intolerance
* Presence of early postoperative complications (e.g., bleeding, persistent vomiting, fistula, obstruction, leakage, infection, etc.)
* Diagnosed dumping syndrome after surgery
* Early postoperative food intolerance or dehydration
* Inability to undergo bioelectrical impedance analysis (e.g., pacemaker, metallic implants)
* Conditions affecting body composition analysis results, such as:
* Menstruation at the time of measurement
* Consumption of food or caffeinated beverages within 4 hours of measurement
* Intense physical activity within 48 hours of measurement
* Non-adherence to daily probiotic/prebiotic supplementation protocol during the intervention period Alcohol consumption within 48 hours of measurement
Source: ClinicalTrials.gov (NCT07051824). StuddyBuddy aggregates publicly available trial information.