The aim of the study is to test the efficacy of the probiotic SmartProbio C in patients with a severe course of COVID-19 infection. Patients were randomly divided into two arms between the probiotic group and the placebo group. They were further divided into four groups according to 1) BMI (Body mass index; \<=30/\>30), 2) age (\<=65/\>65), 3) CRP (C-reactive protein; \<=100/\>100), 4) chronic lung disease (yes/no). Gut microbiome analysis and its changes in selected parameters (amount of lactobacilli, bifidobacteria, Akkermansia, Proteobacteria, Firmicutes/Bacteroidetes ratio) were chosen as the primary endpoint. Other assessed indicators include: * Tracking of time to clinical improvement by two points on a seven-point ordinal scale for clinical improvement according to R\&D Blueprint: COVID-19 Therapeutic Trial Synopsis (WHO, 2020) or time to hospital discharge (whichever comes first) * Monitoring the length of oxygen dependence * Monitoring of laboratory markers of inflammation - serum peripheral blood CRP levels * Monitoring of mortality
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
83
Probiotic supplement consisting of 19 strains (Lactobacillus acidophilus NCFM, Bifidobacterium lactis, subsp. Infantis Bi-07, Lactobacillus rhamnosus LR22, Lactobacillus acidophilus LA14, Lactobacillus rhamnosus LGG, Bifidobacterium lactis HN019, Bifidobacterium lactis Bl-04, Lactobacillus acidophilus LA 11 ONLLY, Lactobacillus rhamnosus HN001, Lactobacillus plantarum LP ONLLY, Lactobacillus casei LC18, Bifidobacterium breve BB8, Lactobacillus reuteri LE16, Bifidobacterium lactis BI516, Streptococcus thermophilus ST6, Bifidobacterium animalis BA77, Bifidobacterium bifidum BB47, Bifidobacterium longum BL88 ONLLY, Bifidobacterium infantis BI211) in different ratios. Probiotic mixture enclosed in HPMC (hydroxypropylmethylcelulose) capsule, 25 billion CFU (colony-forming units) in each capsule. As a filling agent mix of inulin and maltodextrin was used. Dosage twice a day.
Placebo. HPMC (hydroxypropylmethylcelulose) capsule filled with maltodextrin. Dosage twice a day.
Medi Pharma Vision
Brno, Czechia
Brno University Hospital
Brno, Czechia
Gut microbiome
Changes in selected parameters of gut microbiome (amount of lactobacilli, bifidobacteria, Akkermansia, Proteobacteria, and Firmicutes/Bacteroidetes ratio) were chosen as the primary endpoint.
Time frame: The first sample was taken at the beginning of hospitalization before the start of supplementation, the second at discharge from the hospital, but not later than on the 14th day of hospitalization.
Length of hospitalisation
Tracking of time to clinical improvement by two points on a seven-point ordinal scale for clinical improvement according to R\&D Blueprint: COVID-19 Therapeutic Trial Synopsis (WHO, 2020), or time to hospital discharge (whichever comes first).
Time frame: From the date of admission to hospital until discharge from hospital or above defined two point improvement, whichever comes first
Monitoring the length of oxygen dependence
Measurement of the time it was necessary to provide HFOT (high flow oxygen therapy) to the patient
Time frame: From the beginning of the provision of HFOT (high flow oxygen therapy) to the end of the provision of HFOT
CRP (C-reactive protein) monitoring
Monitoring of laboratory marker of inflammation - serum peripheral blood CRP levels
Time frame: On the first day of admission to hospital and on the day of hospital discharge, but no later than 14th day
Monitoring mortality rates
The percentage of deaths in the placebo group compared to percentage of deaths in the verum group
Time frame: From the date of admission to hospital until discharge from hospital or death, whichever comes first
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