NCT07051824

Probiotic and Prebiotic Use in Early Postoperative Period of Sleeve Gastrectomy

The Effect of Probiotic and Prebiotic Use on Gastrointestinal System and Some Biochemical Parameters in the Early Postoperative Period of Sleeve Gastrectomy Patients

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Ayten Altunsaray · Other Government
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Obesity is a growing global health problem, and bariatric surgery particularly sleeve gastrectomy, has become an effective method for long-term weight management. However, postoperative gastrointestinal changes, dysbiosis, and metabolic adaptations remain significant challenges, especially during the initial recovery period. The gut microbiota plays a critical role in digestion, nutrient absorption, immune modulation, and metabolic regulation. Probiotics and prebiotics may contribute to restoring microbial balance, enhancing intestinal barrier integrity, and improving biochemical profiles following surgery. This randomized controlled trial was designed to evaluate the impact of synbiotic supplementation on gastrointestinal symptoms and selected biochemical parameters in patients undergoing sleeve gastrectomy. A total of 60 patients aged 18 to 65 years, with a body mass index (BMI) of 35 or higher, were enrolled. Participants were randomly assigned to two groups in a 1:1 ratio. The intervention group (n = 30) received a 5 g sachet containing maltodextrin (4.9 g) and Lactobacillus rhamnosus GG (1×10⁹ CFU) in a partially hydrolyzed guar gum matrix, administered once daily mixed into 200 ml of yogurt for 12 weeks postoperatively. The control group (n = 30) received no supplementation. In the early postoperative period, patients commonly experience gastrointestinal symptoms such as bloating, gas, and constipation. This study aims to determine whether synbiotic supplementation can alleviate these symptoms and positively affect gastrointestinal function, anthropometric measurements, and specific biochemical markers. Additionally, it explores participants' knowledge and awareness of microbiota-related concepts, including probiotics and prebiotics. Data were collected through validated questionnaires assessing gastrointestinal symptoms, constipation severity, dietary habits, and microbiota-related knowledge. Anthropometric and biochemical assessments were conducted at baseline and at weeks 4 and 12 postoperatively.

Conditions

• Sleeve Gastrectomy
• Gastrointestinal Symptoms
• Prebiotic
• Probiotic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Probiotic and Prebiotic	This synbiotic intervention aims to minimize postoperative gastrointestinal symptoms in sleeve gastrectomy patients. The 5 g sachet contains: * Partially hydrolyzed guar gum (PHGG; 4.9 g): Clinically shown to reduce diarrhea and improve stool consistency, * Lactobacillus rhamnosus GG (LGG; 1×10⁹ CFU): Evidence-based for alleviating abdominal pain and bloating, * Maltodextrin (0.1 g): Excipient for stability. Administered daily in yogurt for 12 weeks post-surgery, this combination directly targets: ① Diarrhea and constipation (via PHGG's soluble fiber), ② Abdominal pain and bloating (via LGG's anti-inflammatory effects), ③ Overall GI symptom burden. \*\*Distinctive features vs. other studies: * Symptom-specific formulation: PHGG (high-dose fiber) + LGG (symptom-targeted probiotic) synergy, * Surgical context: Optimized for rapid gastric transit post-sleeve gastrectomy, * Delivery innovation: Yogurt matrix protects probiotics against surgical gut pH changes.

Timeline

• Start date: 2025-01-24
• Primary completion: 2025-04-22
• Completion: 2025-06-16
• First posted: 2025-07-04
• Last updated: 2025-07-04

Locations

1 site across 1 country: Turkey (Türkiye)