Status:
COMPLETED
Probiotics and Hemodynamic Changes in Cirrhosis
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Cirrhosis
Eligibility:
All Genders
18-70 years
Phase:
NA
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.
Detailed 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 - ...
Eligibility Criteria
Inclusion
- Cirrhosis
- Child-Pugh class B or C;
- Age between 18 and 70 years;
- Signed informed consent.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 29 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05231772
Start Date
March 1 2021
End Date
March 29 2022
Last Update
March 31 2022
Active Locations (1)
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1
Clinic for Internal Diseases, Gastroenterology and Hepatology at Sechenov University
Moscow, Russia, 119435