NCT04756466

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 201 (actual)
• Sponsor: Biosearch S.A. · Industry
• Sex: All
• Age: 60 Years
• Healthy volunteers: Accepted

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.

Conditions

• SARS CoV-2 Infection
• Elderly

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Placebo	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
DIETARY_SUPPLEMENT	Lactobacillus	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

Timeline

• Start date: 2021-01-01
• Primary completion: 2021-04-30
• Completion: 2021-12-31
• First posted: 2021-02-16
• Last updated: 2024-10-21

Locations

3 sites across 1 country: Spain