Probiotic and Prebiotic Use in Early Postoperative Period of Sleeve Gastrectomy

NCT ID: NCT07051824

Last Updated: 2025-07-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-24
• Study Completion Date: 2025-06-16

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Intervention Group (Probiotic and Prebiotic)

Participants received a daily 5 g sachet containing:

• Partially hydrolyzed guar gum (PHGG): 4.9 g (prebiotic fiber),
• Lactobacillus rhamnosus GG (LGG): 1×10⁹ CFU (probiotic),
• Maltodextrin: 0.1 g (excipient).

The sachet was mixed with 200 ml yogurt and consumed as an afternoon snack for 12 weeks post-surgery.

Group Type: EXPERIMENTAL

Probiotic and Prebiotic

Intervention Type: DIETARY_SUPPLEMENT

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.

Control Group (No intervention)

Standard Care Control Participants followed routine post-operative care without dietary supplements.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Maltodextrin + Guar Gum + L. rhamnosus GG; Prebiotic + Probiotic Blend; PHGG + LGG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ayten Altunsaray

OTHER_GOV

Sponsor Role: lead

Responsible Party

Ayten Altunsaray

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ayhan Dağ, Assoc. Prof.

Role: STUDY_CHAIR

Lokman Hekim University

Locations

Türk Obezite Cerrahisi Vakfı

Ankara, Çankaya, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

20240239

Identifier Type: -

Identifier Source: org_study_id