Probiotics and Hemodynamic Changes in Cirrhosis

I.M. Sechenov First Moscow State Medical University40 enrolled

Overview

This is a single-center blinded randomized interventional placebo-controlled study of the effect of probiotics on hemodynamic parameters and liver function in cirrhosis.

Forty patients with Child-Pugh class B and C cirrhosis will be randomized in a 1.5:1 ratio to test and control arms. Patients in the test arm will receive probiotic Saccharomyces boulardii (A07FA02 - Saccharomyces (Enterol) Biocodex Ltd, France, registration number LP-000622 from 21.09.2011) for 3 months, patients in the control arm will receive placebo for 3 months. All patients also will receive standard treatment: spironolactone 100 mg/day in ascites and carvedilol 12.5 mg/day in esophageal varices. The patients will be blinded. At inclusion and after 3 months after starting of probiotic/placebo treatment, systemic hemodynamics parameters (cardiac output and systemic vascular resistance), liver function (serum albumin and total bilirubin level, international normalized ratio, presence and degree of ascites or hepatic encephalopathy), the gut microbiome, biomarkers of bacterial translocation (presepsin, lipopolysaccharide), intestinal permeability (claudin 3), systemic inflammation (tumor necrosis factor alpha ) and endothelial dysfunction (nitrites, endothelin) will be assessed. After the end of the study, an interim analysis of the effect of the probiotic on aforementioned systemic hemodynamics and liver function indicators will be carried out. If there is a positive effect, a full analysis of all the aforementioned factors contributing to its development will be performed.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Cirrhosis

Interventions

Saccharomyces Boulardii Probiotic SupplementDRUG

Probiotic yeast

PlaceboDRUG

Placebo

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Cirrhosis * Child-Pugh class B or C; * Age between 18 and 70 years; * Signed informed consent. Exclusion Criteria: * Use of lactulose, lactitol, or other prebiotics, probiotics, antibiotics, or metformin in the past 6 weeks before inclusion; * Alcohol consumption in the past 6 weeks before inclusion; * Inflammatory bowel disease; * Cancer; * Prematurely discontinuation of the consumption of tested probiotic/placebo; * Started taking antibiotics, other probiotics, or prebiotics during the follow-up period; * Refusal to participate during the follow-up period.

Locations (1)

Clinic for Internal Diseases, Gastroenterology and Hepatology at Sechenov University

Moscow, Russia

Outcomes

Primary Outcomes

the change in cardiac output

Transthoracic echocardiography (with Acuson S2000 by Siemens Ltd, USA, registration number 2017/6109 from 24.07.2018) according to the guidelines of the American Society of Echocardiography (published in 2015) with a simultaneous assessment of blood pressure (with semi-automatic tonometer UA-604 by AND Ltd, Japan, registration number 2011/09642 from 10.10.2018) and heart rate will be performed to assess systemic hemodynamics. Cardiac output will be calculated as (stroke volume) × (heart rate).

Time frame: at inclusion and 3 months after the start of the study

the change in number of points on the Child-Pugh scale

The scale assesses the degree of hyperbilirubinemia (1 point - serum total bilirubin level is less than 2 mg / dl, 2 points - 2-3 mg / dl, 3 points - above 3 mg / dl), hypoalbuminemia (1 point - serum albumin level above 35 g / l, 2 points - 28-35 g / l, 3 points - less than 28 g / l), hypocoagulation (1 point - international normalized ratio less than 1.7, 2 points - 1.7-2.3, 3 points - above 2.3) degree of ascites (1 points - no ascites, 2 points - ascites detected only with ultrasound, 3 points - large ascites visible to the eyes) of hepatic encephalopathy (1 point - no hepatic encephalopathy; 2 points - hepatic encephalopathy without severe manifestations (stupor or coma); 3 points - severe hepatic encephalopathy (stupor or coma)).

Time frame: at inclusion and 3 months after the start of the study

Secondary Outcomes

the change in the serum albumin level

venous blood will be take on an empty stomach at 7-9 am without any special preparation

Time frame: at inclusion and 3 months after the start of the study

the change in the serum total bilirubin level

venous blood will be take on an empty stomach at 7-9 am without any special preparation

Time frame: at inclusion and 3 months after the start of the study

Data from ClinicalTrials.gov

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