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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- SARS CoV-2 Infection
- Sponsor
- Biosearch S.A.
- Enrollment
- 201
- Locations
- 3
- Primary Endpoint
- Incidence of SARS CoV-2 infection.
- Status
- Completed
- Last Updated
- last year
Overview
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.
Investigators
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-
- •Person with concomitant disease type HIV, transplant, active cancer or other type of active immunosuppression.
Outcomes
Primary Outcomes
Incidence of SARS CoV-2 infection.
Time Frame: 3 months
Incidence of SARS CoV-2 infection confirmed by PCR or antigen test
Secondary Outcomes
- Serum levels of IgG antibody against SARS-CoV-2(6-weeks from second dose of the vaccine)
- Use of pharmacological treatments.(3 months)
- Days of persistent feeling of fatigue.(3 months)
- Incidence of need for oxygen support due to SARS-CoV-2 infection..(3 months)
- Incidence of hospital admissions caused by SARS-CoV-2 infection .(3 months)
- Incidence of ICU admissions caused by SARS-CoV-2 infection(3 months)
- Serum levels of IgA antibody against SARS-CoV-2(6-weeks from second dose of the vaccine)
- Incidence of pneumonia caused by SARS-CoV-2 infection .(3 months)
- Days with body temperature> 37.5ºC.(3 months)
- Days of persistent cough.(3 months)
- Incidence of gastrointestinal symptoms due to SARS-CoV-2 infection.(3 months)