Probiotics and Microbiota in Bariatric Surgery
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Hepato-Renal Index (HRI) method by abdominal US
研究概览
简要总结
This study is a randomized clinical trial with 6 months probiotic supplement vs. placebo treatment and 6 month follow up on 100 NAFLD patients that will undergo sleeve gastrectomy surgery. Measurements will be conducted at: baseline, M3 (3 months after treatment initiation), M6 and M12 and will include: abdominal US, Fibroscan, biochemical tests, anthropometric measurements, glucose breath test for bacterial overgrowth, fecal samples and questionnaires for demographic details, quality of life, food intake, food tolerance and habitual physical activity. 20 subjects will undergo an additional liver-MRI test at baseline and M6.
Additionally, 30 healthy participants will consume probiotic supplement vs. placebo for 28 days and will undergo gastroscopy and colonoscopy before and during consumption.
详细描述
Background:
Bariatric surgery is an effective and increasingly common treatment for obesity and obesity-related comorbidities. Among patients undergoing bariatric surgery, as many as 96% have NAFLD (Nonalcoholic fatty liver disease) and up to 25% have NASH (Nonalcoholic steatohepatitis). Intestinal microbiota has been shown to play pivotal roles in host mammalian developmental, immune and metabolic functions. Alterations in the gut microbiome, or 'dysbiosis' has been recently linked to the pathogenesis of metabolic disease including obesity, insulin resistance, atherosclerosis and liver diseases. Recent studies show that modulation of gut microbiota may represent a novel way to treat or prevent NAFLD and its progression. Bariatric surgery is associated with major modifications in microbiota composition, quantity and function. Potential mediators to the gut microbiota are probiotics which are considered to be a safe therapy since its microorganisms composition is found naturally in human microflora. Clinical research has shown that probiotic supplementation can induce physiological changes in the intestinal flora (e.g., via the secretion of endogenic antibiotics and other defensins). Moreover, It was shown that probiotic bacteria are assimilated in the gut mucosa, thus replacing and changing the natural bacterial line-up. The biopsies taken in the healthy section of the study will help us evaluate all the above changes, after 4 weeks of probiotic intervention.
To date, there is lack of evidence on the use of probiotics in bariatric surgeries with just 1 randomizes clinical trial in Roux-en-Y gastric bypass surgery patients.
Aims:
To evaluate the effect of 6 months probiotic supplement vs. placebo on clinical and metabolic parameters in patients with NAFLD undergoing sleeve gastrectomy surgery.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Subjects 18-65 years old
- •BMI > 40 kg/m² or BMI > 35 kg/m² with comorbidities (See Appendix 1 for the Ministry of health indications for bariatric surgeries) that got the bariatric commission approval of Assuta private hospitals to undergo sleeve gastrectomy surgery
- •Willingness to take a probiotic/placebo supplement once a day for 6 months
- •Ultrasound diagnosed NAFLD patients
- •Reading and speaking Hebrew
- •Healthy volunteers:
- •Subjects 18-65 years old
- •Healthy subjects
排除标准
- •Subject with mental illness or cognitive deterioration
- •Use of probiotic/antibiotic 3 mounts before surgery
- •Use of other antibiotic for more than 1 week during the study
- •Drug addiction
- •Excessive alcohol consumption (≥ 30 g/day in men or ≥ 20 g/day in women)
- •Treatment with drugs known to cause hepatic steatosis or elevation of liver enzymes (e.g. Corticosteroids, HAART, Amiodarone, high dose estrogens) (see Appendix 2)
- •Treatment with drugs or supplements that may improve hepatic steatosis or liver enzymes (Vitamin E, Milk thistle, ω-3 fatty acid, Ursodeoxycholic acid) 3 months prior to the initiation of the study
- •Other causes of chronic liver disease ( e.g. viral hepatitis: HBV/HCV +, autoimmune hepatitis, Hemochromatosis, Wilson's disease)
- •Diabetic patients who are treated with antidiabetic medications, except diabetic patients who are treated for at least 6 months exclusively with Metformin at a stable dose
- •Subjects who began a new lipid reduction medications less than 6 months prior to the initiation of the study
- •Subjects with chronic conditions that could interfere with our study: active cancer, organ transplant subjects, advanced kidney or liver disease, inflammatory bowel disease and other systemic inflammatory conditions
- •Bariatric surgery in the past
结局指标
主要结局
Hepato-Renal Index (HRI) method by abdominal US
时间窗: 36 months
US will be performed at pretrial, 6 ,12 , 36 months after the surgery. .Fatty liver will be diagnosed by abdominal US using standardized criteria. HRI, a validated quantitative measure, will be calculated on the basis of the ratio between the echogenicity of the liver and that of the right kidney cortex using histogram echo intensity.
次要结局
- Liver fibrosis - by Fibroscan (transient elastography)(36 months)
- Hand grip(36 months)
- Biochemical fasting blood tests(36 months)
- Microbiome composition and function(6 years)
- Anthropometric measurements(36 months)
- The fecal microbiota composition(6 years)
- Food tolerance after bariatric surgery(36 months)
- Quality of life (QoL)(36 months)
- Liver MRI(6 months)
研究者
michal roll
Director, r&d division
Tel-Aviv Sourasky Medical Center