Probiotics in NASH Patients - PROBILIVER TRIAL
关键词
抽象
描述
In this randomized clinical trial (RCT) will include adult outpatients linked to the Gastroenterology Service of the Hospital de Clínicas de Porto Alegre (Hospital of Clinics of Porto Alegre-HCPA) -Brazil with diagnosis of NAFLD confirmed by biopsy and transient elastography. Patients who are cirrhotic, pregnant, co-infected or who have Chronic Kidney Disease will not be included. All patients, after signing the Written Informed Consent Form, will undergo a complete anamnesis to investigate alcohol consumption (AUDIT, Alcohol Use Disorders Identification Test), smoking, previous history, medications in use, food consumption assessment (through a 3-day food record), physical activity level and physical and functional capacity (International Physical Activity Questionnaire, sit-to-stand test, unipodal, walk test and dynamometry), body composition (Electrical bioimpedance, dual energy x-ray absorptiometry (DEXA), anthropometric measurements), cardiovascular risk (Framingham Score and Atherosclerotic Cardiovascular Disease - ASCVD), biochemical parameters for assessment of inflammatory status [C-reactive protein (CRP), toll-like receptor 4 (TLR4)], lipid profile (total cholesterol, HDL, LDL, triglycerides), hepatic function [cytokeratin-18 (CK18), aspartate aminotransferase (AST), alanine aminotransferase (ALT), gamma-glutamyltransferase (GGT), bilirubin, alkaline phosphatase], as well as blood glucose level , insulin, albumin, creatinine and complete blood count and even assessment of gut microbiota (patients will be provided with a kit for collecting feces and from the extraction of DNA from stool samples, after which a metagenomic analysis will be performed). These procedures will be performed at baseline and repeated after 24 weeks (at the end of the study). Through the of process of randomization (randomization.com), the patients will be allocated to receive treatment A or B. As for patients and researchers involved both are blinded (double-blind study). The intervention consists of treatment with probiotic mix (Lactobacillus acidophilus 1x109 colony-forming unit (CFU) + Bifidobacterium lactis 1x109 CFU + Lactobacillus rhamnosus 1x109 CFU + Lactobacillus paracasei 1x109 CFU) and the placebo identical in characteristics and packaging (polydextrose/maltodextrin). Patients will be instructed to consume 2 sachets/day during 24 weeks. Patients will be instructed to report any symptoms or para effects related to the use of sachets and adherence control will be carried out through the patient's notes on a form provided and also by checking the number of sachets.
日期
最后验证: | 05/31/2020 |
首次提交: | 03/08/2018 |
提交的预估入学人数: | 03/08/2018 |
首次发布: | 03/14/2018 |
上次提交的更新: | 06/16/2020 |
最近更新发布: | 06/18/2020 |
实际学习开始日期: | 11/28/2017 |
预计主要完成日期: | 07/30/2020 |
预计完成日期: | 12/19/2021 |
状况或疾病
干预/治疗
Dietary Supplement: Probiotic
Dietary Supplement: Placebo
相
手臂组
臂 | 干预/治疗 |
---|---|
Experimental: Probiotic 1g probiotic mix (twice day): Lactobacillus acidophilus 1x109 CFU + Bifidobacterium lactis 1x109 CFU + Lactobacillus rhamnosus 1x109 CFU + Lactobacillus paracasei 1x109 CFU | Dietary Supplement: Probiotic 1g probiotic mix (twice day): Lactobacillus acidophilus 1x109 CFU + Bifidobacterium lactis 1x109 CFU + Lactobacillus rhamnosus 1x109 CFU + Lactobacillus paracasei 1x109 CFU |
Placebo Comparator: Placebo 1g polydextrose/maltodextrin - twice day | Dietary Supplement: Placebo 1g polydextrose/maltodextrin - twice day |
资格标准
有资格学习的年龄 | 18 Years 至 18 Years |
有资格学习的性别 | All |
接受健康志愿者 | 是 |
标准 | Inclusion Criteria: - adult outpatient with diagnostic of NAFLD Exclusion Criteria: - HIV, hepatitis B virus (HBV) or hepatitis C virus (HCV) infected patients - significant intake of alcohol - cirrhosis, - pregnant women, - transplanted patients, - intake of supplements or foods containing probiotics, - immunosuppressants, antibiotics, corticosteroids, valproic acid and amiodarone, - other chronic inflammatory diseases |
结果
主要结果指标
1. hepatic fibrosis [24 weeks]
2. cardiovascular risk [24 weeks]
次要成果指标
1. diversity of gut microbiota [24 weeks]
2. inflammation by TLR4 expression [24 weeks]
3. inflammation by CK18 expression [24 weeks]
4. inflammation by serum C-reactive protein [24 weeks]
5. metabolic syndrome [24 weeks]
6. change in body composition by DEXA [24 weeks]
7. body composition by bioimpedance [24 weeks]
8. change in hand grip strength [24 weeks]
9. change in physical ability [24 weeks]
10. change in the parameters of sarcopenia by serum myostatin [24 weeks]
11. change in the parameters of sarcopenia by serum testosterone [24 weeks]