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Probiotic and Prebiotic Use in Early Postoperative Period of Sleeve Gastrectomy

NCT07051824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-07-04

No results posted yet for this study

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.

Conditions

  • Sleeve Gastrectomy
  • Gastrointestinal Symptoms
  • Prebiotic
  • Probiotic

Interventions

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.

Sponsors & Collaborators

  • Ayten Altunsaray

    lead OTHER_GOV

Principal Investigators

  • Ayhan Dağ, Assoc. Prof. · Lokman Hekim University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-24
Primary Completion
2025-04-22
Completion
2025-06-16

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07051824 on ClinicalTrials.gov