Probiotics and Hemodynamic Changes in Cirrhosis (PrBHCCir)

I.M. Sechenov First Moscow State Medical University

Status: Completed

Conditions: Cirrhosis

Treatments: Drug: Placebo; Drug: Saccharomyces Boulardii Probiotic Supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05231772

2533644

Details and patient eligibility

About

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

Full description

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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

40 participants in 2 patient groups, including a placebo group

Probiotics

Experimental group

Description:

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.

Treatment:

Drug: Saccharomyces Boulardii Probiotic Supplement

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebo