open access

Vol 8, No 4 (2019)
ORIGINAL ARTICLES
Published online: 2019-09-19
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Probiotics and smectite absorbent gel formulation reduce liver stiffness, transaminase and cytokine levels in NAFLD associated with type 2 diabetes: a randomized clinical study

Nazarii Kobyliak, Ludovico Abenavoli, Galyna Mykhalchyshyn, Tetyana Falalyeyeva, Olena Tsyryuk, Liudmyla Kononenko, Dmytro Kyriienko, Iuliia Komisarenko
DOI: 10.5603/DK.2019.0016
·
Clinical Diabetology 2019;8(4):205-214.

open access

Vol 8, No 4 (2019)
ORIGINAL ARTICLES
Published online: 2019-09-19

Abstract

Introduction. In double-blind single center randomized clinical trial (RCT), the efficacy of alive probiotics sup­plementation with smectite gel vs. placebo in type 2 diabetes patient with non-alcoholic fatty liver disease (NAFLD) detected on ultrasonography (US) were studied.

Material and methods. A total of 50 patients met the criteria for inclusion. They were randomly assigned to receive Symbiter Forte combination of probiotic biomass with smectite gel (250 mg) or placebo for 8-weeks. The primary main outcomes were the change in fatty liver index (FLI) and liver stiffness (LS) meas­ured by shear wave elastography (SWE). Secondary outcomes were the changes in transaminases activity, serum lipids and cytokines levels.

Results. All subjects completed the study and received more than 90% of prescribed sachets. In respect to our primary endpoints, FLI and LS insignificant de­crease in both interventional and placebo groups. However, when we compare mean changes across groups from baseline, expressed in absolute values, the reduction of both LS (–0.254 ± 0.85 vs. 0.262 ± 0.77; p = 0.031) were observed. Analysis of sec­ondary outcomes showed that co-administration of probiotic with smectite lead to significant reduction of alanine aminotransferase (ALT), aspartate amino­transferase (AST), total cholesterol, IL-1b, and tumor necrosis factor (TNF-a) after 8 weeks.

Conclusion. In this RCT, we confirmed previously re­ported animal data, showing that co-administration of probiotic with smectite manifested with reduction of LS, liver transaminases and chronic systemic inflam­mation.

Abstract

Introduction. In double-blind single center randomized clinical trial (RCT), the efficacy of alive probiotics sup­plementation with smectite gel vs. placebo in type 2 diabetes patient with non-alcoholic fatty liver disease (NAFLD) detected on ultrasonography (US) were studied.

Material and methods. A total of 50 patients met the criteria for inclusion. They were randomly assigned to receive Symbiter Forte combination of probiotic biomass with smectite gel (250 mg) or placebo for 8-weeks. The primary main outcomes were the change in fatty liver index (FLI) and liver stiffness (LS) meas­ured by shear wave elastography (SWE). Secondary outcomes were the changes in transaminases activity, serum lipids and cytokines levels.

Results. All subjects completed the study and received more than 90% of prescribed sachets. In respect to our primary endpoints, FLI and LS insignificant de­crease in both interventional and placebo groups. However, when we compare mean changes across groups from baseline, expressed in absolute values, the reduction of both LS (–0.254 ± 0.85 vs. 0.262 ± 0.77; p = 0.031) were observed. Analysis of sec­ondary outcomes showed that co-administration of probiotic with smectite lead to significant reduction of alanine aminotransferase (ALT), aspartate amino­transferase (AST), total cholesterol, IL-1b, and tumor necrosis factor (TNF-a) after 8 weeks.

Conclusion. In this RCT, we confirmed previously re­ported animal data, showing that co-administration of probiotic with smectite manifested with reduction of LS, liver transaminases and chronic systemic inflam­mation.

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Keywords

diosmectite; nutraceuticals; non-alcoholic fatty liver disease; probiotics; Lactobacillus; Bifidobacterium; Propionibacterium

About this article
Title

Probiotics and smectite absorbent gel formulation reduce liver stiffness, transaminase and cytokine levels in NAFLD associated with type 2 diabetes: a randomized clinical study

Journal

Clinical Diabetology

Issue

Vol 8, No 4 (2019)

Pages

205-214

Published online

2019-09-19

DOI

10.5603/DK.2019.0016

Bibliographic record

Clinical Diabetology 2019;8(4):205-214.

Keywords

diosmectite
nutraceuticals
non-alcoholic fatty liver disease
probiotics
Lactobacillus
Bifidobacterium
Propionibacterium

Authors

Nazarii Kobyliak
Ludovico Abenavoli
Galyna Mykhalchyshyn
Tetyana Falalyeyeva
Olena Tsyryuk
Liudmyla Kononenko
Dmytro Kyriienko
Iuliia Komisarenko

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