The Effect of Probiotic and Prebiotic Use on Gastrointestinal System and Some Biochemical Parameters in the Early Postoperative Period of Sleeve Gastrectomy Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Bristol Stool Consistency Scale
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Voluntary participation (provided informed consent)
- •Age between 18 and 65 years
- •Body mass index (BMI) ≥ 35 kg/m²
- •Underwent laparoscopic sleeve gastrectomy
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Probiotic and Prebiotic (Dietary Supplement)
Control Group (No intervention)
Standard Care Control Participants followed routine post-operative care without dietary supplements.
结局指标
主要结局
Bristol Stool Consistency Scale
时间窗: Baseline, week 4, week 12
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.
Change in Blood Glucose and Insulin Parameters
时间窗: Baseline, Week 4, Week 12
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.
Change in Lipid Biomarkers
时间窗: Baseline, Week 4, Week 12
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.
Change in Liver Function and Related Biochemical Parameters
时间窗: Baseline, Week 4, Week 12
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.
Change in Gastrointestinal Symptom Rating Scale (GSRS) Scores
时间窗: Baseline, Week 4, Week 12
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.
Constipation Severity Scale (CSS) Score
时间窗: Baseline, week 4, week 12
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.
Gas/Bloating Scale
时间窗: Baseline, week 4, week 12
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.
Other biochemical parameters
时间窗: Baseline, Week 4, Week 12
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.
次要结局
- 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)
研究者
Ayten Altunsaray
Principal Investigator
Lokman Hekim Üniversitesi