Randomized Controlled Trial
Copyright ©The Author(s) 2022. Published by Baishideng Publishing Group Inc. All rights reserved.
World J Hepatol. Aug 27, 2022; 14(8): 1667-1677
Published online Aug 27, 2022. doi: 10.4254/wjh.v14.i8.1667
Effect of probiotics on hemodynamic changes and complications associated with cirrhosis: A pilot randomized controlled trial
Roman Maslennikov, Irina Efremova, Vladimir Ivashkin, Maria Zharkova, Elena Poluektova, Elena Shirokova, Konstantin Ivashkin
Roman Maslennikov, Irina Efremova, Vladimir Ivashkin, Maria Zharkova, Elena Poluektova, Elena Shirokova, Konstantin Ivashkin, Department of Internal Medicine, Gastroenterology and Hepatology, Sechenov University, Moscow 119435, Russia
Roman Maslennikov, Vladimir Ivashkin, Elena Poluektova, The Scientific Community for Human Microbiome Research, Moscow 119435, Russia
Roman Maslennikov, Consultative and Diagnostic Center No. 2 of Moscow Health Department , Moscow 107764, Russia
Author contributions: Ivashkin V provided the research idea; Ivashkin V, Efremova I, and Roman Maslennikov R designed the study; Efremova I and Maslennikov R wrote the draft; Maslennikov R was the guarantor; All authors edited the draft and contributed to the research and data analysis.
Supported by Biocodex Microbiota Foundation: National Research Grant Russia 2019.
Institutional review board statement: The study was approved by the Ethics Committee of Sechenov University.
Clinical trial registration statement: The study was registered at https://clinicaltrials.gov (NCT05231772).
Informed consent statement: The study procedures were explained to potential participants, and written informed consent was obtained before enrollment.
Conflict-of-interest statement: All authors report no relevant conflicts of interest for this article.
Data sharing statement: Data can be provided upon request to the corresponding author.
CONSORT 2010 statement: The authors have read the CONSORT Statement—checklist of items, and the manuscript was prepared and revised according to the CONSORT Statement—checklist of items.
Open-Access: This article is an open-access article that was selected by an in-house editor and fully peer-reviewed by external reviewers. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: https://creativecommons.org/Licenses/by-nc/4.0/
Corresponding author: Roman Maslennikov, MD, PhD, Assistant Professor, Department of Internal Medicine, Gastroenterology and Hepatology, Sechenov University, Pogodinskaya Street 1, Moscow 119435, Russia. mmmm00@yandex.ru
Received: February 15, 2022
Peer-review started: February 15, 2022
First decision: March 9, 2022
Revised: April 12, 2022
Accepted: July 26, 2022
Article in press: July 26, 2022
Published online: August 27, 2022
Processing time: 191 Days and 11 Hours
Abstract
BACKGROUND

Bacterial translocation exacerbates the hyperdynamic circulation observed in cirrhosis and contributes to a more severe disease course. Probiotics may reduce bacterial translocation and may therefore be useful to redress the circulatory imbalance.

AIM

To investigate the effect of probiotics on hemodynamic parameters, systemic inflammation, and complications of cirrhosis in this randomized placebo-controlled trial.

METHODS

This single-blind randomized placebo-controlled study included 40 patients with Child-Pugh class B and C cirrhosis; 24 patients received probiotics (Saccharomyces boulardii) for 3 mo, and 16 patients received a placebo over the same period. Liver function and the systemic hemodynamic status were evaluated pre- and post-intervention. Echocardiography and simultaneous blood pressure and heart rate monitoring were performed to evaluate systemic hemodynamic indicators. Cardiac output and systemic vascular resistance were calculated.

RESULTS

Following a 3-mo course of probiotics in comparison to the control group, we observed amelioration of hyperdynamic circulation [a decrease in cardiac output (P = 0.026) and an increase in systemic vascular resistance (P = 0.026)] and systemic inflammation [a decrease in serum C-reactive protein levels (P = 0.044)], with improved liver function [an increase in serum albumin (P = 0.001) and a decrease in the value of Child-Pugh score (P = 0.001)] as well as a reduction in the severity of ascites (P = 0.022), hepatic encephalopathy (P = 0.048), and cholestasis [a decrease in serum alkaline phosphatase (P = 0.016) and serum gamma-glutamyl transpeptidase (P = 0.039) activity] and an increase in platelet counts (P < 0.001) and serum sodium level (P = 0.048).

CONCLUSION

Probiotic administration was associated with amelioration of hyperdynamic circulation and the associated complications of cirrhosis.

Keywords: Gut; Gut-liver axis; Microbiota; Hemodynamics; Heart; Gut-heart axis; Saccharomyces boulardii; Portal hypertension

Core Tip: Bacterial translocation exacerbates the hyperdynamic circulation observed in cirrhosis and contributes to a more severe disease course. Probiotics may reduce bacterial translocation and may therefore be useful to redress the circulatory imbalance. The aim of the study was to investigate the effect of probiotics on hemodynamic parameters, systemic inflammation, and complications of cirrhosis in this randomized placebo-controlled trial. Following a 3-mo course of probiotics, we observed amelioration of hyperdynamic circulation and systemic inflammation, improvement liver function, regression of ascites and hepatic encephalopathy, and an increase in serum sodium level.