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

NCT ID: NCT04756466

Last Updated: 2024-10-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 201 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-01
• Study Completion Date: 2021-12-31

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.

Conditions

SARS CoV-2 Infection; Elderly

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

Control group

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Probiotic group

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

Group Type: EXPERIMENTAL

Lactobacillus

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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

Intervention Type: 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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Biosearch S.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mónica Olivares, PhD

Role: STUDY_DIRECTOR

Biosearch S.A.

Anxo Fernandez-Ferreiro, PhD

Role: PRINCIPAL_INVESTIGATOR

Complejo Hospitalario Universitario de Santiago Compostela

Locations

Residencia San Marcos

Santiago de Compostela, A Coruña, Spain

Residencia Santa Olalla

Santiago de Compostela, A Coruña, Spain

Residencia San Simon de Ons

Santiago de Compostela, A Coruña, Spain

Countries

Spain

Other Identifiers

P055

Identifier Type: -

Identifier Source: org_study_id