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Efficacy of Probiotics in the Treatment of Hospitalised Patients With Novel Coronavirus Infection

Primary Purpose

Coronavirus Infection

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
Probiotics
Sponsored by
I.M. Sechenov First Moscow State Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronavirus Infection focused on measuring Novel Coronavirus Infection, Probiotics, Lactobacillus, Bifidobacterium, Clinical outcomes, C.difficile, Diarrhea, Liver, mortality

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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 Criteria:

  • 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)

Sites / Locations

  • I.M. Sechenov First Moscow State Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Probiotics group (PRO)

Control group (CON)

Arm Description

99 patients with COVID-19 infection who have been supplemented with a Lactobacillus and Bifidobacterium containing probiotic in addition to standard regimen (oxygen support, antiviral, antibacterial, anticoagulant, anticytokine (tocilizumab and olokizumab) drugs and dexamethasone treatment according to indications and contraindications)

101 patients with COVID-19 infection who have been treated with standard regimen only (oxygen support, antiviral, antibacterial, anticoagulant, anticytokine (tocilizumab and olokizumab) drugs and dexamethasone treatment according to indications and contraindications)

Outcomes

Primary Outcome Measures

Mortality
The number of died patients during hospitalization

Secondary Outcome Measures

Duration of hospitalization
The number of days patients stayed at hospital
Total duration of the disease
The number of days patients had complaints
Incidence of admission to intensive care unit
The number of patients admitted to the intensive care unit during hospitalization
Need for non-invasive ventilation
The number of patients requiring a non-invasive ventilation during hospitalization
Days of non-invasive ventilation
The number of days that patients had non-invasive ventilation during hospitalization
Need for invasive ventilation
The number of patients requiring an invasive ventilation during hospitalization
Changes in the values of C-reactive protein level in serum
The values of C-reactive protein level (mg/L) in serum of the patients during hospitalization
Changes in the counts of white blood cells in blood test
The counts of white blood cells (10^9/L) in blood test of the patients during hospitalization
Changes in the counts of neutrophils in blood test
The counts of neutrophils (10^9/L) in blood test of the patients during hospitalization
Changes in the counts of lymphocytes
The counts of lymphocytes (10^9/L) in blood test of the patients during hospitalization
Changes in the counts of platelets
The counts of platelets (10^9/L) in blood test of the patients during hospitalization
Changes in the values of erythrocyte sedimentation rate in in blood test
The values of erythrocyte sedimentation rate (mm/hr) in blood test of the patients during hospitalization
Changes in the values of creatinine level in serum
The values of creatinine (μmol/l) level in serum of the patients during hospitalization
Changes in the values of alanine aminotransferase (ALT) level in serum
The values of alanine aminotransferase (ALT) level (u/L) in serum of the patients during hospitalization
Changes in the values of aspartate aminotransferase level in serum
The values of aspartate aminotransferase (AST) level (u/L) in serum of the patients during hospitalization
Changes in the values of albumen level in serum
The values of albumen level (g/L) in serum of the patients during hospitalization
Changes in the values of total bilirubin level in serum
The values of total bilirubin level (μmol/l) in serum of the patients during hospitalization
Changes in the values of lactate dehydrogenase level in serum
The values of lactate dehydrogenase (LDH) level (u/l) in serum of the patients during hospitalization
Changes in the values of ferritin level in serum
The values of ferritin level (μg/l) in serum of the patients during hospitalization
Changes in the values of fibrinogen level in serum
The values of fibrinogen level (g/l) in serum of the patients during hospitalization
Changes in the values of potassium level in serum
The values of potassium level (mmol/l) in serum of the patients during hospitalization
Incidence of diarrhoea
The number of patients with diarrhea (loose or watery stools or frequent bowel movements more than three times a day) during hospitalization
The duration of diarrhoea
The number of days that the patients had diarrhea (loose or watery stools or frequent bowel movements more than three times a day)
The maximum volume of the affected lungs
The volume of the affected lungs counted by the sum of ground glass and consolidation volumes (%) using chest computed tomography (CT)

Full Information

First Posted
April 7, 2021
Last Updated
January 13, 2022
Sponsor
I.M. Sechenov First Moscow State Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04854941
Brief Title
Efficacy of Probiotics in the Treatment of Hospitalised Patients With Novel Coronavirus Infection
Official Title
Efficacy of Probiotics (Lactobacillus Rhamnosus, Bifidobacterium Bifidum, Bifidobacterium Longum Subsp. Infantis and Bifidobacterium Longum) in the Treatment of Hospitalised Patients With Novel Coronavirus Infection
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
December 10, 2020 (Actual)
Primary Completion Date
March 10, 2021 (Actual)
Study Completion Date
April 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
I.M. Sechenov First Moscow State Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 assumed, that changes in composition of intestinal microbiota is closely related to a change in the regulation of the immune response in the lungs in patients with COVID-19. These gut microbiota changes in combination with antibiotic prescription during the treatment increase the risk of antibiotic-associated diarrhea and C. difficile infection as well as worse clinical outcomes in these patients. Probiotics are useful for restoring the human gut microbiome and increasing anti-inflammatory response also. Despite the variety of uses of probiotics, there is still insufficient data on the clinical efficacy of including probiotics in the treatment of patients with COVID-19 infection.
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 First Moscow State Medical University in whom the disease was confirmed using polymerase chain reaction on nasopharyngeal and oropharyngeal swabs to detect severe acute respiratory syndrome-related coronavirus 2 (SARS-COV-2). The study was conducted from December 2020 to March 2021 and included participants in the age range from 18 to 75 years. The exclusion criteria were age over 75 years or under 18 years, consumption of 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, cancer or mental illness, and severe renal (glomerular filtration rate less than 50 mL/min) or hepatic (equivalent to cirrhosis class B or C on the Child-Pugh scale) dysfunction at the time of admission. Patients who prematurely discontinued the consumption of probiotics for reasons not related to the development of side effects were excluded from the study. The patients were randomised to the probiotics group (PRO group) or the control group (CON group). Patients in the PRO group received probiotics containing ~109 colony forming units (CFU) of Lactobacillus rhamnosus PDV 1705, ~109 CFU of Bifidobacterium bifidum PDV 0903, ~109 CFU of B. longum subsp. infantis PDV 1911, and ~109 CFU of B. longum PDV 2301 three times a day during the hospital stay but for no more than 14 days (PDV is the commercial letter designation of the bacterial strains). The end point of the trial was day 14 of hospitalisation or the day of the patient's discharge or death, whichever occurred earlier. The control group consisted of patients who did not receive probiotics. Patients in both the groups also received dexamethasone and antiviral (favipiravir and/or riamilovir), antibacterial, anticoagulant (enoxaparin in most cases; rivaroxaban and dabigatran were used much less frequently), and anticytokine (tocilizumab or/and olokizumab) drugs according to indications and contraindications. Death from any cause was considered the primary outcome. Duration of hospitalisation, total duration of the disease, incidence of admission to intensive care unit, need for oxygen support or mechanical ventilation, and changes in the values of key biomarkers were considered the main secondary outcomes. The duration of diarrhoea [loose or watery stools or an increase in the frequency of bowel movements (more than three times per day)] and incidence of hospital-acquired diarrhoea as well as the progression of pre-existing liver injury and onset of liver injury were considered additional secondary outcomes. Liver injury was determined through the presence of abnormalities in any of the main liver test findings (serum alanine transaminase, aspartate transaminase, alkaline phosphatase, gamma-glutamyl transferase, total bilirubin, and albumin levels). The volume of the affected lungs was measured using chest computed tomography (CT); it included the sum of ground glass and consolidation volumes. Results are presented as the median [interquartile range]. The groups were compared using Mann-Whitney test for continuous data and chi-square test for categorical data. Wilcoxon test was used to assess the changes in continuous biomarker values. Mortality was assessed using the Kaplan-Meier estimator and Cox's test. A p value ≤0.05 was considered the criterion for significance. Statistical calculations were performed using "Statistica 10" soft (TIBCO Software inc, Palo Alto, CA)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronavirus Infection
Keywords
Novel Coronavirus Infection, Probiotics, Lactobacillus, Bifidobacterium, Clinical outcomes, C.difficile, Diarrhea, Liver, mortality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotics group (PRO)
Arm Type
Experimental
Arm Description
99 patients with COVID-19 infection who have been supplemented with a Lactobacillus and Bifidobacterium containing probiotic in addition to standard regimen (oxygen support, antiviral, antibacterial, anticoagulant, anticytokine (tocilizumab and olokizumab) drugs and dexamethasone treatment according to indications and contraindications)
Arm Title
Control group (CON)
Arm Type
No Intervention
Arm Description
101 patients with COVID-19 infection who have been treated with standard regimen only (oxygen support, antiviral, antibacterial, anticoagulant, anticytokine (tocilizumab and olokizumab) drugs and dexamethasone treatment according to indications and contraindications)
Intervention Type
Other
Intervention Name(s)
Probiotics
Intervention Description
Probiotics (10^9 CFU of each strain: Lactobacillus rhamnosus PDV 1705, Bifidobacterium bifidum PDV 0903, Bifidobacterium longum subsp. infantis PDV 1911 and Bifidobacterium longum PDV 2301) 3 times per day in addition to standard treatment regimen for 2 weeks
Primary Outcome Measure Information:
Title
Mortality
Description
The number of died patients during hospitalization
Time Frame
During hospitalization (Since the first day of hospitalization to the day of the patient's discharge)
Secondary Outcome Measure Information:
Title
Duration of hospitalization
Description
The number of days patients stayed at hospital
Time Frame
Since the first day of hospitalization to the day of the patient's discharge
Title
Total duration of the disease
Description
The number of days patients had complaints
Time Frame
Since the first day of hospitalization to the day of the patient's discharge
Title
Incidence of admission to intensive care unit
Description
The number of patients admitted to the intensive care unit during hospitalization
Time Frame
at the 14th day of hospitalization or at the day of the patient's discharge
Title
Need for non-invasive ventilation
Description
The number of patients requiring a non-invasive ventilation during hospitalization
Time Frame
at the 14th day of hospitalization or at the day of the patient's discharge
Title
Days of non-invasive ventilation
Description
The number of days that patients had non-invasive ventilation during hospitalization
Time Frame
at the 14th day of hospitalization or at the day of the patient's discharge
Title
Need for invasive ventilation
Description
The number of patients requiring an invasive ventilation during hospitalization
Time Frame
at the 14th day of hospitalization or at the day of the patient's discharge
Title
Changes in the values of C-reactive protein level in serum
Description
The values of C-reactive protein level (mg/L) in serum of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Changes in the counts of white blood cells in blood test
Description
The counts of white blood cells (10^9/L) in blood test of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Changes in the counts of neutrophils in blood test
Description
The counts of neutrophils (10^9/L) in blood test of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Changes in the counts of lymphocytes
Description
The counts of lymphocytes (10^9/L) in blood test of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Changes in the counts of platelets
Description
The counts of platelets (10^9/L) in blood test of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Changes in the values of erythrocyte sedimentation rate in in blood test
Description
The values of erythrocyte sedimentation rate (mm/hr) in blood test of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Changes in the values of creatinine level in serum
Description
The values of creatinine (μmol/l) level in serum of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Changes in the values of alanine aminotransferase (ALT) level in serum
Description
The values of alanine aminotransferase (ALT) level (u/L) in serum of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Changes in the values of aspartate aminotransferase level in serum
Description
The values of aspartate aminotransferase (AST) level (u/L) in serum of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Changes in the values of albumen level in serum
Description
The values of albumen level (g/L) in serum of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Changes in the values of total bilirubin level in serum
Description
The values of total bilirubin level (μmol/l) in serum of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Changes in the values of lactate dehydrogenase level in serum
Description
The values of lactate dehydrogenase (LDH) level (u/l) in serum of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Changes in the values of ferritin level in serum
Description
The values of ferritin level (μg/l) in serum of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Changes in the values of fibrinogen level in serum
Description
The values of fibrinogen level (g/l) in serum of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Changes in the values of potassium level in serum
Description
The values of potassium level (mmol/l) in serum of the patients during hospitalization
Time Frame
at the first and at the 14th day of hospitalization (or at the first day and at day of the patient's discharge)
Title
Incidence of diarrhoea
Description
The number of patients with diarrhea (loose or watery stools or frequent bowel movements more than three times a day) during hospitalization
Time Frame
at 14th day of hospitalization (or at the day of the patient's discharge)
Title
The duration of diarrhoea
Description
The number of days that the patients had diarrhea (loose or watery stools or frequent bowel movements more than three times a day)
Time Frame
at 14th day of hospitalization (or at the day of the patient's discharge)
Title
The maximum volume of the affected lungs
Description
The volume of the affected lungs counted by the sum of ground glass and consolidation volumes (%) using chest computed tomography (CT)
Time Frame
at 14th day of hospitalization (or at the day of the patient's discharge)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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)
Facility Information:
Facility Name
I.M. Sechenov First Moscow State Medical University
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The provision of data is prohibited by Local Ethical Committee and is possible upon receipt of an official request addressed to the principal investigator
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Efficacy of Probiotics in the Treatment of Hospitalised Patients With Novel Coronavirus Infection

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