Status:
COMPLETED
Efficacy of Probiotics in the Treatment of Hospitalised Patients With Novel Coronavirus Infection
Lead Sponsor:
I.M. Sechenov First Moscow State Medical University
Conditions:
Coronavirus Infection
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
The treatment of the new coronavirus infection (COVID-19) and COVID-19-associated diarrhoea and liver injury remains challenging. Optimizing treatment approaches for COVID-19 remains an issue. It is a...
Detailed Description
A randomized controlled open-label study approved by the local ethical committee. The study included patients with COVID-19 admitted to the T.M. Tareev Clinic of Internal Diseases of I.M. Sechenov Fir...
Eligibility Criteria
Inclusion
- patients with COVID-19 infection confirmed by polymerase chain reaction of nasopharyngeal and oropharyngeal swabs to the causative agent of this infection
- age from 18 to 75 years old from December 2020 to April 2021
Exclusion
- the patient's decision to withdraw from the study
- refusing to take the probiotic for a reason not related to the development of side effects.
- Non-inclusion criteria:
- age over 75 years old or under 18 years old,
- taking probiotics for 3 months prior to admission
- history of intolerance to probiotics or their components
- refusal to participate and sign informed consent
- pregnancy or breastfeeding
- presence of cancer or psychoemotional disorders
- renal failure at the time of admission (glomerular filtration rate less than 50 ml / min)
- hepatic failure at the time of admission (equivalent to cirrhosis class B or C on the Child-Pugh scale)
Key Trial Info
Start Date :
December 10 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 10 2021
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04854941
Start Date
December 10 2020
End Date
April 10 2021
Last Update
January 28 2022
Active Locations (1)
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1
I.M. Sechenov First Moscow State Medical University
Moscow, Russia, 119991