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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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SARS CoV-2 Infection, Elderly

Intervention / Treatment
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* Dietary Supplement: Placebo
* Dietary Supplement: Lactobacillus


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>Control group that will receive a daily placebo capsule consisting of maltodextrin during 3 months | Dietary Supplement: Placebo<br>* 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<br>|
| Experimental: Probiotic group<br>Experimental group that will receive one capsule with the probiotic strain per day (3x10 9 CFU / day) during 3 months | Dietary Supplement: Lactobacillus<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of SARS CoV-2 infection. | Incidence of SARS CoV-2 infection confirmed by PCR or antigen test | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 3 months | 
| 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 | 3 months | 
| 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 | 3 months | 
| 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. | 3 months | 
| 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. | 3 months | 
| 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 | 3 months | 
| Days of persistent cough. | In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days with persistent cough | 3 months | 
| 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. | 3 months | 
| Use of pharmacological treatments. | In case of SARS-CoV-2 infection confirmed by PCR or antigen test, use of pharmacological treatments | 3 months | 
| 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 | 6-weeks from 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 | 6-weeks from second dose of the vaccine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Probiotics, COVID19