Abstract

Background

Recently factors in the relationship between gut microbiota, obesity, diabetes and the metabolic syndrome have been suggested in the development and progression of nonalcoholic steatohepatitis (NASH). In this sense, this work aims to evaluate the effects of probiotic supplementation on intestinal microbiota modulation, degree of hepatic steatosis and fibrosis, inflammation, gut permeability, and body composition.

Methods

This double-blind, randomized clinical trial will include adult outpatients with a diagnosis of NASH confirmed by biopsy with or without transient elastography. All patients will undergo a complete anamnesis to investigate their alcohol consumption, previous history, medications, nutritional assessment (dietary intake and body composition), sarcopenia, physical activity level and physical and functional capacity, cardiovascular risk, biochemical parameters for assessment of inflammatory status, lipid profile, hepatic function, gut permeability, and assessment of microbiota. These procedures will be performed at baseline and repeated after 24 weeks (at the end of the study). Through the process of randomization, patients will be allocated to receive treatment A or treatment B. Both patients and researchers involved will be blinded (double-blind study). The intervention consists of treatment with a probiotic mix (Lactobacillus acidophillus + Bifidobacterium lactis + Lactobacillus rhamnosus + Lactobacillus paracasei, 1 x 109 CFU for each) and the placebo which is identical in all its characteristics and packaging. Patients will be instructed to consume two sachets/day during 24 weeks and to report any symptoms or side effects related to the use of the sachets. Adherence control will be carried out through the patient’s notes on a form provided, and also by checking the number of sachets used.

Discussion

The final results of study will be analyzed and disseminated in 2020.

Trial registration

ClinicalTrials.gov, ID: NCT03467282. Registered on 15 March 2018.

Details

Title
Effect of probiotic supplementation in nonalcoholic steatohepatitis patients: PROBILIVER TRIAL protocol
Author
Silva-Sperb, Amanda Souza 1   VIAFID ORCID Logo  ; Moraes, Helena Abadie 1 ; de Moura, Bruna Concheski 1 ; Alves, Bruna Cherubini 1 ; Bruch-Bertani, Juliana Paula 2 ; Azevedo, Vittoria Zambon 3 ; Dall’Alba, Valesca 4 

1  Universidade Federal do Rio Grande do Sul (UFRGS), Graduate Program: Sciences of Gastroenterology and Hepatology, Porto Alegre, Brazil (GRID:grid.8532.c) (ISNI:0000 0001 2200 7498) 
2  Universidade do Vale do Taquari, Department of Nutrition, Lajeado, Brazil (GRID:grid.441846.b) 
3  UFRGS, Graduate Program in Food, Nutrition and Health, Porto Alegre, Brazil (GRID:grid.8532.c) (ISNI:0000 0001 2200 7498) 
4  Universidade Federal do Rio Grande do Sul (UFRGS), Graduate Program: Sciences of Gastroenterology and Hepatology, Porto Alegre, Brazil (GRID:grid.8532.c) (ISNI:0000 0001 2200 7498); UFRGS, Graduate Program in Food, Nutrition and Health, Porto Alegre, Brazil (GRID:grid.8532.c) (ISNI:0000 0001 2200 7498); Hospital de Clínicas de Porto Alegre, Nutrition and Dietetics Division, Porto Alegre, Brazil (GRID:grid.414449.8) (ISNI:0000 0001 0125 3761); UFRGS, Department of Nutrition, School of Medicine, Porto Alegre, Brazil (GRID:grid.8532.c) (ISNI:0000 0001 2200 7498) 
Pages
580
Publication year
2019
Publication date
Dec 2019
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-019-3679-7
ProQuest document ID
2795368671
Copyright
© The Author(s). 2019. This work is published under http://creativecommons.org/licenses/by/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.