Probiotic and Prebiotic Use in Early Postoperative Period of Sleeve Gastrectomy

NCT07051824 | Completed

• 1 other identifier: 20240239
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleeve Gastrectomy; Gastrointestinal Symptoms; Prebiotic; Probiotic

Keywords

Gastrointestinal Symptoms; Prebiotic; Probiotic; Sleeve Gastrectomy

Outcome Measures

Primary Outcomes (8)

• Change in Gastrointestinal Symptom Rating Scale (GSRS) Scores

  The Gastrointestinal Symptom Rating Scale (GSRS) was used to evaluate participants' gastrointestinal symptoms before surgery, at 4 weeks post-surgery, and at 12 weeks post-surgery. The scale has five subscales targeting abdominal pain, reflux, diarrhea, indigestion, and constipation. Higher scores on the scale indicate more severe symptoms. Between-group comparisons were conducted using independent t-test and changes over time were analyzed with 2 (group) × 3 (time) repeated measures ANOVA.

  Baseline, Week 4, Week 12

• Constipation Severity Scale (CSS) Score

  The Constipation Severity Scale (CSS) was administered to participants before surgery, at 4 weeks post-surgery, and at 12 weeks post-surgery. It is a measure designed to determine the frequency, intensity, and difficulty/strain of bowel movements. The scale consists of 16 questions. The CCS has three subscales: Stool Impaction, Colon Sluggishness, and Pain. The score for the Stool Impaction subscale ranges from 0 to 28, the score for the Colon Sluggishness subscale ranges from 0 to 29, and the score for the Pain subscale ranges from 0 to 16. The total score that can be obtained from the CSS ranges from a minimum of 0 to a maximum of 73. A high score on the scale indicates the severity of the symptoms. Between-group comparisons were conducted using independent t-test and changes over time were analyzed with 2 (group) × 3 (time) repeated measures ANOVA.

  Baseline, week 4, week 12

• Gas/Bloating Scale

  The Gas/Bloating Scale was used to determine participants' gas/bloating symptoms before surgery, at 4 weeks post-surgery, and at 12 weeks post-surgery. It is designed to measure the frequency, severity, impact, and discomfort caused by gas/bloating symptoms. The scale consists of 12 questions, with each question scored on a scale from 0 to 4. According to the scoring system, 0 points indicate no symptoms, 1 point indicates minimal symptoms, 2-5 points indicate mild symptoms, 6-13 points indicate moderate symptoms, and 14 or more points indicate severe symptoms. Between-group comparisons were conducted using the chi-square and changes over time were analyzed with 2 (group) × 3 (time) repeated measures ANOVA.

  Baseline, week 4, week 12

• Bristol Stool Consistency Scale

  The Bristol Stool Consistency Scale is a scale of stool types ranging from the hardest to the softest. Type 1 stool is considered to be hard, nut-like lumps that are difficult to pass through the intestines. Type 2 stool is also lumpy but sausage-shaped. Types 1 and 2 are considered abnormally hard stools. Type 3 stools have cracks on the surface and are sausage-shaped, Type 4 stools are smooth and soft like a snake, and Type 5 stools are soft pieces with distinct edges and are easy to pass. Types 3, 4, and 5 are generally considered "normal" stool forms. The Friedman test was applied to evaluate the distribution of changes in Bristol scores over time in the study and control groups before surgery, at 4 weeks post-surgery, and at 12 weeks post-surgery. The chi-square test was used to compare the distribution and statistical comparisons of the study and control groups before surgery and at 4 and 12 weeks post-surgery according to the Bristol Stool Consistency Scale.

  Baseline, week 4, week 12

• Change in Blood Glucose and Insulin Parameters

  Blood glucose homeostasis was evaluated using fasting glucose (mg/dL), fasting insulin (µIU/mL), and HOMA-IR (Homeostatic Model Assessment of Insulin Resistance) index, calculated using the formula \[fasting blood sugar (mg/dL) x fasting insulin (µIU/mL)/405\]. All values were extracted from clinical records at three time points. These variables were analyzed separately.An independent t-test was used to assess whether there were statistically significant differences between the groups.

  Baseline, Week 4, Week 12

• Change in Lipid Biomarkers

  To evaluate the participants' blood lipid profiles, the following parameters were assessed: Cholesterol (mg/dL), HDL (High-Density Lipoprotein) (mg/dL), LDL (Low-Density Lipoprotein) (mg/dL), Triglycerides (mg/dL). Each value was extracted from medical records and analyzed separately. Independent t-tests were used to compare values between intervention and control groups.

  Baseline, Week 4, Week 12

• Change in Liver Function and Related Biochemical Parameters

  Liver function and associated biomarkers were evaluated through the following laboratory values: Alanine Aminotransferase - ALT (U/L) Aspartate Aminotransferase - AST (U/L) Gamma-Glutamyl Transferase - GGT (U/L) Values were obtained from participants' medical records and assessed at baseline, 4th and 12th postoperative weeks. Independent t-tests were used to compare values between intervention and control groups.

  Baseline, Week 4, Week 12

• Other biochemical parameters

  Serum uric acid (mg/dL) Total Bilirubin (mg/dL) Direct Bilirubin (mg/dL) levels were assessed in all participants at three time points: before surgery, and at 4 and 12 weeks postoperatively. Values were obtained from patient medical records. Differences between intervention and control groups were analyzed using independent t-tests.

  Baseline, Week 4, Week 12

Secondary Outcomes (4)

• Change in anthropometric measurements

  Baseline, Week 4, Week 12

• Change in Body Composition Parameters

  Baseline, Week 4, Week 12

• Change in physical activity levels

  Baseline, Week 4, Week 12

• Baseline group differences in Microbiota Awareness Scores (MAS)

  Baseline only

Study Arms (2)

Intervention Group (Probiotic and Prebiotic)

EXPERIMENTAL

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.

Dietary Supplement: Probiotic and Prebiotic

Control Group (No intervention)

NO INTERVENTION

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

Interventions

Probiotic and Prebiotic 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.

Also known as: Maltodextrin + Guar Gum + L. rhamnosus GG, Prebiotic + Probiotic Blend, PHGG + LGG

Intervention Group (Probiotic and Prebiotic)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary participation (provided informed consent)
• Age between 18 and 65 years
• Body mass index (BMI) ≥ 35 kg/m²
• Underwent laparoscopic sleeve gastrectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Ayten Altunsaray: lead

Study Sites (1)

Türk Obezite Cerrahisi Vakfı

Ankara, Çankaya, 06680, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Probiotics; Prebiotics; maltodextrin; guar gum

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dietary Fiber; Dietary Carbohydrates; Carbohydrates; Polysaccharides, Bacterial; Polysaccharides

Study Officials

• Ayhan Dağ, Assoc. Prof.

  Lokman Hekim University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 17, 2025
• First Posted: July 4, 2025
• Study Start: January 24, 2025
• Primary Completion: April 22, 2025
• Study Completion: June 16, 2025
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)