Efficacy and Safety of a Probiotic Composition as Adjunct Treatment in the Comprehensive Management of Metabolism-Associated Hepatic Steatosis in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in alanine amino transferase (ALT)
研究概览
简要总结
Some studies have shown beneficial results with probiotics on hepatic function of subjects with fatty liver, but significant variability has been noted among probiotic formulations. This study aims at providing a comprehensive characterization of the effect of a particular probiotic formula in hepatic function of said subjects.
详细描述
Some studies have shown beneficial results with probiotics on hepatic function of subjects with Non-Alcoholic Fatty Liver (NAFL) also known as Metabolism-Associated Fatty Liver (MAFL). However, meta-analyses have found significant variability among probiotic formulations. In fact, many probiotic properties are thought to be strain-specific.
This study aims at providing a comprehensive characterization of a particular probiotic formula containing Lactoplantibacillus plantarum (formerly Lactobacillus plantarum) and Levilactobacillus brevis (formerly Lactobacillus brevis) in hepatic function of individuals with NAFL. The study will assess hepatic stiffness via transient elastography (Fibroscan), hepatic function via liver enzymes in serum (ALT, AST, GGT) and liver-specific inflammation via cytokeratin18 in serum, as well as some general metabolic and inflammatory markers.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Active and placebo capsules are indistinguishable in form, color and taste, and provided in coded boxes. List containing the correspondence between codes and treatment group assignment is prepared by a pharmacist not participating in the study and kept in a sealed envelope until the end of the study.
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Hepatic Steatosis associated with Metabolism (MAFL, also known as Non-Alcoholic Fatty Liver or NAFL) with Controlled Attenuation Parameter (CAP) value of > 269 dB / m when evaluated by Fibroscan transient elastography
- •Alanine aminotransferase (ALT) levels at least 35% above the upper limit of reference values
- •BMI between 25 and 40 kg / m2
- •Signing of the informed consent and understanding of the procedures to be carried out
- •Not willing to change their current dietary habits (hypercaloric and hyperlipemic)
排除标准
- •Treatment of NAFL or NASH (Non-Alcoholic Steato-Hepatitis) for at least 3 months prior to the study, with high dose vitamin E (≥200 mg / day), high dose omega-3 (≥500 mg / day), pioglitazone, bile acid sequestrants, statins, GLP-1 agonists, and / or DPP4 inhibitors ("gliptins"), and not having shown a significant biochemical and ultrasonographic improvement
- •History of chronic alcohol or drug abuse
- •Diagnosis of infectious hepatitis or HIV infection
- •Diagnosis of hemochromatosis
- •Celiac disease, inflammatory bowel disease, chronic or recurrent diarrhea
- •Chronic use of laxatives.
- •Pancreatic failure, thyroid dysfunction, severe liver disease, biliary dysfunction (including cholecystectomy and blood bilirubin abnormalities)
- •Uncontrolled diabetes or hypertriglyceridemia greater than 500mg / dL
- •History of regular use (> 3 days) of oral or parenteral antibiotics one month prior to the study
- •Current use of systemic corticosteroids, androgens, clopidogrel, digoxin, acenocoumarol, warfarin, phenytoin, topiramate, lithium, tricyclic antidepressants, monoamine oxidase inhibitors, second generation antipsychotics, amiodarone, tamoxifen, and/or diltiazem.
- •Intake of other probiotics, plant-derived sterols, beta-glucans, red rice yeast (Monascus purpureus), or milk thistle extract (Silybum marianum) or its active ingredients (silymarin, silybin) on a regular basis (> 7 days) in the 15 days prior to entering the study.
- •History of angina or cardiovascular events, cancer, or immunosuppression
- •Chronic, moderate-to-heavy smoking (> 5 cigarettes a day)
- •History of gastro-intestinal surgery in the previous year.
- •Debilitating diseases (advanced liver or kidney disease, severe depression, psychotic symptoms, neurological diseases).
- •Current pregnancy (positive urine test), or planning to become pregnant during the course of the study.
- •Breastfeeding at the time of eligibility assessment
- •Subjects having participated in a clinical study within 1 month prior to eligibility assessment
- •Current use of 4 or more concomitant medications of any type
结局指标
主要结局
Change in alanine amino transferase (ALT)
时间窗: change month 4 from baseline
Change in serum levels (international units/L) of alanine amino transferase (ALT) across the study. Sample obtained through blood sampling
次要结局
- Change in Fatty Liver Index(change month 4 from baseline)
- Change in leptin serum parameters(change month 4 from baseline)
- Change in Hepatic Steatosis Index(change month 4 from baseline)
- Change in Cholesterol(change month 4 from baseline)
- Change in Fibroscan-AST score(change month 4 from baseline)
- Change in ferritin serum parameters(change month 4 from baseline)
- Change in hepatic steatosis(change month 4 from baseline)
- Change in adiponectin serum parameters(change month 4 from baseline)
- Change in HOMA serum parameters(change month 4 from baseline)
- Change in glucose serum parameters(change month 4 from baseline)
- Change in glycosylated hemoglobin serum parameters(change month 4 from baseline)
- Change in C-reactive protein serum parameters(change month 4 from baseline)
- Change in Cytokeratin-18 serum parameters(change month 4 from baseline)
- Intestinal microbiota composition(change month 4 from baseline)
- Change in waist / height index(change month 4 from baseline)
- Change in insulin serum parameters(change month 4 from baseline)
- Change in Triglycerides serum parameters(change month 4 from baseline)
- Change in BMI values(change month 4 from baseline)
- Change in IL-1beta serum parameters(change month 4 from baseline)
- Change in waist values(change month 4 from baseline)
- Change in hip circumference values(change month 4 from baseline)
- Adverse events(Throughout study completion, an average of 4 months)
- Change in TNF-alpha serum parameters(change month 4 from baseline)
- Change in IL-17 serum parameters(change month 2 from baseline)
- Change in fat values(change month 4 from baseline)