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

Biosearch Life

Status: Completed

Conditions: Elderly; SARS CoV-2 Infection

Treatments: Dietary Supplement: Lactobacillus; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT04756466

P055

Details and patient eligibility

About

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.

Full 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.

Enrollment: 201 patients

Sex: All

Ages: 60+ years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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201 participants in 2 patient groups, including a placebo group

Control group

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo

Probiotic group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Lactobacillus