Abstract
BackgroundRecently 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.MethodsThis 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.DiscussionThe final results of study will be analyzed and disseminated in 2020.Trial registrationClinicalTrials.gov, ID: NCT03467282. Registered on 15 March 2018.
Highlights
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)
The gut microbiota seems to be related to non-alcoholic fatty-liver disease (NAFLD)/ NASH by contributing to intestinal permeability and choline-metabolism disturbance, endogenous-alcohol production, inflammatory cytokine release, and hepatic Toll-like receptor (TLR) regulation
Patients allocated to the intervention group will receive probiotic supplementation which consists of a 1-g sachet containing Lactobacillus acidophilus SD5221 (1 x 109 CFU) + Lactobacillus rhamnosus SD5675 (1 x 109 CFU) + Lactobacillus paracasei SD5275 (1 x 109 CFU) + Bifidobacterium lactis SD5674 (1 x 109 CFU), while those allocated to the control group will receive a 1-g sachet with an identical appearance containing polydextrose/maltodextrin as the placebo
Summary
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. Patients with NASH with a higher degree of fibrosis and concurrent metabolic diseases, such as diabetes, hypertension, visceral obesity, and dyslipidemia, present a higher mortality risk Patients with this profile have a greater requirement for treatment [1]. Some studies have suggested that patients with NASH have a different microbiota composition than patients without the disease [5]
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