Skip to main content
OpenTrials
Completed

NCT Number: NCT05231772

Probiotics and Hemodynamic Changes in Cirrhosis

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cirrhosis Fibrosis Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clinic for Internal Diseases, Gastroenterology and Hepatology at Sechenov University

Moscow, 119435, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Saccharomyces Boulardii Probiotic Supplement

Drug

Probiotic yeast

Other names: Probiotics, Enterol

Placebo

Drug

Placebo

Other names: No other name

Primary outcomes

  1. the change in cardiac output

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

    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).

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

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

    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)).

Secondary outcomes

  1. the change in the serum albumin level

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

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

  2. the change in the serum total bilirubin level

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

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

  3. the change in the international normalized ratio

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

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

  4. the change in the serum C-reactive protein level

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

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

  5. the change in systemic vascular resistance

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

    systemic vascular resistance will be calculated as mean arterial pressure/cardiac output

  6. the change in the degree of hepatic encephalopathy

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

    0 - no hepatic encephalopathy, 1 - minimal hepatic encephalopathy (normal neurological status but abnormal number connection test), 2 - overt hepatic encephalopathy (abnormal neurological status)

  7. the change in the degree of ascites

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

    0 points - no ascites, 1 points - ascites detected only with ultrasound, 2 points - ascites detected with the shifting dullness method; 3 point - gross refractory ascites.

  8. the change in the presence of small intestinal bacterial overgrowth

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

    lactulose hydrogene breath test with Gastro+Gastrolyzer (by Bedfont Ltd, the United kingdom, registration number 2010/06253 from 17.09.2020) in accordance with the North American Consensus: the presence of small intestinal bacterial overgrowth is considered when there was an increase in breath hydrogen of at least 20 ppm above the baseline value within 90 minutes after taking 10 ml of lactulose dissolved in 200 ml of water.

  9. the change in the serum presepsin level

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

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

  10. the change in the serum lipopolysaccharide level

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

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

  11. the change in the serum claudin 3 level

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

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

  12. the change in the serum tumor necrosis factor alpha level

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

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

  13. the change in the serum nitrites level

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

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

  14. the change in the serum big endothelin level

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

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

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

The Effect of Probiotics on Hemodynamic Changes and Complications of Cirrhosis

Acronym: PrBHCCir

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 9, 2022
Registry last updated
Mar 31, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.