Probiotics and Hemodynamic Changes in Cirrhosis

NCT05231772 | Completed

• 1 other identifier: 2533644
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cirrhosis

Keywords

gut-liver axis; microbiota; microbiome; liver; cirrhosis; hemodynamics

Outcome Measures

Primary Outcomes (2)

• 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).

  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)).

  at inclusion and 3 months after the start of the study

Secondary Outcomes (14)

• the change in the serum albumin level

  at inclusion and 3 months after the start of the study

• the change in the serum total bilirubin level

  at inclusion and 3 months after the start of the study

• the change in the international normalized ratio

  at inclusion and 3 months after the start of the study

• the change in the serum C-reactive protein level

  at inclusion and 3 months after the start of the study

• the change in systemic vascular resistance

  at inclusion and 3 months after the start of the study

Study Arms (2)

Probiotics

EXPERIMENTAL

Patients in the Test arm will receive Saccharomyces boulardii (Saccharomyces), (Enterol), Biocodex Ltd, France, registration number LP-000622 from 21.09.2011 at a dose of 250 mg 2 times a day for 3 months.

Drug: Saccharomyces Boulardii Probiotic Supplement

Placebo

PLACEBO COMPARATOR

Patients in the Placebo arm will receive the placebo at a dose of 250 mg 2 times a day for 3 months.

Drug: Placebo

Interventions

Saccharomyces Boulardii Probiotic Supplement DRUG

Probiotic yeast

Also known as: Probiotics, Enterol

Probiotics

Placebo DRUG

Placebo

Also known as: No other name

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Cirrhosis
• Child-Pugh class B or C;
• Age between 18 and 70 years;
• Signed informed consent.

You may not qualify if:

• 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.

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

Clinic for Internal Diseases, Gastroenterology and Hepatology at Sechenov University

Moscow, 119435, Russia

Location

Related Publications (4)

• Maslennikov R, Ivashkin V, Efremova I, Poluektova E, Shirokova E. Gut-liver axis in cirrhosis: Are hemodynamic changes a missing link? World J Clin Cases. 2021 Nov 6;9(31):9320-9332. doi: 10.12998/wjcc.v9.i31.9320.

  PMID: 34877269 BACKGROUND

• Maslennikov R, Ivashkin V, Efremova I, Alieva A, Kashuh E, Tsvetaeva E, Poluektova E, Shirokova E, Ivashkin K. Gut dysbiosis is associated with poorer long-term prognosis in cirrhosis. World J Hepatol. 2021 May 27;13(5):557-570. doi: 10.4254/wjh.v13.i5.557.

  PMID: 34131470 BACKGROUND

• Maslennikov R, Ivashkin V, Efremova I, Poluektova E, Shirokova E. Probiotics in hepatology: An update. World J Hepatol. 2021 Sep 27;13(9):1154-1166. doi: 10.4254/wjh.v13.i9.1154.

  PMID: 34630882 BACKGROUND

• Ivashkin V, Fomin V, Moiseev S, Brovko M, Maslennikov R, Ulyanin A, Sholomova V, Vasilyeva M, Trush E, Shifrin O, Poluektova E. Efficacy of a Probiotic Consisting of Lacticaseibacillus rhamnosus PDV 1705, Bifidobacterium bifidum PDV 0903, Bifidobacterium longum subsp. infantis PDV 1911, and Bifidobacterium longum subsp. longum PDV 2301 in the Treatment of Hospitalized Patients with COVID-19: a Randomized Controlled Trial. Probiotics Antimicrob Proteins. 2023 Jun;15(3):460-468. doi: 10.1007/s12602-021-09858-5. Epub 2021 Oct 13.

  PMID: 34643888 BACKGROUND

MeSH Terms

Conditions

Fibrosis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Vladimir Ivashkin, Prof.

  I.M. Sechenov First Moscow State Medical University (Sechenov University)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 9, 2022
• Study Start: March 1, 2021
• Primary Completion: March 29, 2022
• Study Completion: March 29, 2022
• Last Updated: March 31, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)