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Effect of the Consumption of a Lactobacillus Strain on the Incidence of Covid-19 in the Elderly

Primary Purpose

SARS CoV-2 Infection, Elderly

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Placebo
Lactobacillus
Sponsored by
Biosearch S.A.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for SARS CoV-2 Infection focused on measuring Probiotics, COVID19

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Person over 60 years of age.
  2. Intern in residence for the elderly.
  3. Sign informed consent.

Exclusion Criteria:

  1. Person who at some previous time has tested positive for detection of COVID-19 by PCR or serology.
  2. Person who at the time of starting the intervention presents symptoms compatible with COVID-19.
  3. Person with concomitant disease type HIV, transplant, active cancer or other type of active immunosuppression.

Sites / Locations

  • Residencia San Marcos
  • Residencia Santa Olalla
  • Residencia San Simon de Ons

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control group

Probiotic group

Arm Description

Control group that will receive a daily placebo capsule consisting of maltodextrin during 3 months

Experimental group that will receive one capsule with the probiotic strain per day (3x10 9 CFU / day) during 3 months

Outcomes

Primary Outcome Measures

Incidence of SARS CoV-2 infection.
Incidence of SARS CoV-2 infection confirmed by PCR or antigen test

Secondary Outcome Measures

Incidence of hospital admissions caused by SARS-CoV-2 infection .
Incidence of hospital admissions caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test
Incidence of ICU admissions caused by SARS-CoV-2 infection
Incidence of ICU admissions caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test
Incidence of pneumonia caused by SARS-CoV-2 infection .
Incidence of pneumonia caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test
Incidence of need for oxygen support due to SARS-CoV-2 infection..
Incidence of need for oxygen support due to SARS-CoV-2 infection confirmed by PCR or antigen test.
Incidence of gastrointestinal symptoms due to SARS-CoV-2 infection.
Incidence of gastrointestinal symptoms due to SARS-CoV-2 infection confirmed by PCR or antigen test.
Days with body temperature> 37.5ºC.
In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days with body temperature> 37.5ºC
Days of persistent cough.
In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days with persistent cough
Days of persistent feeling of fatigue.
In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days of persistent feeling of fatigue.
Use of pharmacological treatments.
In case of SARS-CoV-2 infection confirmed by PCR or antigen test, use of pharmacological treatments
Serum levels of IgG antibody against SARS-CoV-2
In case volunteers was vaccinated against SARS-CoV-2, the serum levels of IgG antibody against SARS-CoV-2 will be measured, at 6 weeks from the second dose of the vaccine
Serum levels of IgA antibody against SARS-CoV-2
In case volunteers was vaccinated against SARS-CoV-2, the serum levels of IgA antibody against SARS-CoV-2 will be measured, at 6 weeks from the second dose of the vaccine

Full Information

First Posted
January 21, 2021
Last Updated
March 3, 2021
Sponsor
Biosearch S.A.
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1. Study Identification

Unique Protocol Identification Number
NCT04756466
Brief Title
Effect of the Consumption of a Lactobacillus Strain on the Incidence of Covid-19 in the Elderly
Official Title
Multicenter, Randomized, Double-blind Parallel Group Pilot Study to Evaluate the Effect of the Consumption of a Lactobacillus Strain on the Incidence of Covid-19 in the Elderly
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
April 30, 2021 (Anticipated)
Study Completion Date
December 31, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Biosearch S.A.

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 objective of this trial is to evaluate the effect of the consumption of a probiotic strain on the incidence and severity of COVID-19 in elderly population living in a nursing home. In addition, it will be evaluated if the probiotic strain have some effect on the immune response generated by the Covid-19 vaccine inthis population.
Detailed Description
The working hypothesis is that the administration of a Lactobacillus strain improves the immune response in the elderly population, improving the immune response to a possible COVID-19 infection. The strain would act as an adjuvant that contributes to developing an effective response against the virus, and therefore there are fewer infectious symptoms due to this virus or, if it appears, it occurs in a milder way among the subjects who take the probiotic strain. Also,the investigators hypothesizes that the administration of the Lactobacillus may improve the immune response generated by the Covid-19 vaccine in this elderly population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SARS CoV-2 Infection, Elderly
Keywords
Probiotics, COVID19

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
201 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
Control group that will receive a daily placebo capsule consisting of maltodextrin during 3 months
Arm Title
Probiotic group
Arm Type
Experimental
Arm Description
Experimental group that will receive one capsule with the probiotic strain per day (3x10 9 CFU / day) during 3 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
Intervention Type
Dietary Supplement
Intervention Name(s)
Lactobacillus
Intervention Description
Each participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits
Primary Outcome Measure Information:
Title
Incidence of SARS CoV-2 infection.
Description
Incidence of SARS CoV-2 infection confirmed by PCR or antigen test
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Incidence of hospital admissions caused by SARS-CoV-2 infection .
Description
Incidence of hospital admissions caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test
Time Frame
3 months
Title
Incidence of ICU admissions caused by SARS-CoV-2 infection
Description
Incidence of ICU admissions caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test
Time Frame
3 months
Title
Incidence of pneumonia caused by SARS-CoV-2 infection .
Description
Incidence of pneumonia caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test
Time Frame
3 months
Title
Incidence of need for oxygen support due to SARS-CoV-2 infection..
Description
Incidence of need for oxygen support due to SARS-CoV-2 infection confirmed by PCR or antigen test.
Time Frame
3 months
Title
Incidence of gastrointestinal symptoms due to SARS-CoV-2 infection.
Description
Incidence of gastrointestinal symptoms due to SARS-CoV-2 infection confirmed by PCR or antigen test.
Time Frame
3 months
Title
Days with body temperature> 37.5ºC.
Description
In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days with body temperature> 37.5ºC
Time Frame
3 months
Title
Days of persistent cough.
Description
In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days with persistent cough
Time Frame
3 months
Title
Days of persistent feeling of fatigue.
Description
In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days of persistent feeling of fatigue.
Time Frame
3 months
Title
Use of pharmacological treatments.
Description
In case of SARS-CoV-2 infection confirmed by PCR or antigen test, use of pharmacological treatments
Time Frame
3 months
Title
Serum levels of IgG antibody against SARS-CoV-2
Description
In case volunteers was vaccinated against SARS-CoV-2, the serum levels of IgG antibody against SARS-CoV-2 will be measured, at 6 weeks from the second dose of the vaccine
Time Frame
6-weeks from second dose of the vaccine
Title
Serum levels of IgA antibody against SARS-CoV-2
Description
In case volunteers was vaccinated against SARS-CoV-2, the serum levels of IgA antibody against SARS-CoV-2 will be measured, at 6 weeks from the second dose of the vaccine
Time Frame
6-weeks from second dose of the vaccine

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Person over 60 years of age. Intern in residence for the elderly. Sign informed consent. Exclusion Criteria: Person who at some previous time has tested positive for detection of COVID-19 by PCR or serology. Person who at the time of starting the intervention presents symptoms compatible with COVID-19. Person with concomitant disease type HIV, transplant, active cancer or other type of active immunosuppression.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mónica Olivares, PhD
Organizational Affiliation
Biosearch S.A.
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Anxo Fernandez-Ferreiro, PhD
Organizational Affiliation
Complejo Hospitalario Universitario de Santiago Compostela
Official's Role
Principal Investigator
Facility Information:
Facility Name
Residencia San Marcos
City
Santiago De Compostela
State/Province
A Coruña
ZIP/Postal Code
15820
Country
Spain
Facility Name
Residencia Santa Olalla
City
Santiago De Compostela
State/Province
A Coruña
ZIP/Postal Code
15881
Country
Spain
Facility Name
Residencia San Simon de Ons
City
Santiago De Compostela
State/Province
A Coruña
ZIP/Postal Code
15883
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effect of the Consumption of a Lactobacillus Strain on the Incidence of Covid-19 in the Elderly

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