Clinical trial NCT04756466: Effect of the Consumption of a Lactobacillus Strain on the Incidence of Covid-19 in the Elderly
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: SARS CoV-2 Infection
Elderly
Keywords: Probiotics
COVID19
Lead sponsor: Biosearch S.A.
Sponsor class: INDUSTRY
First posted: 2021-02-16
Enrollment: 201
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Incidence of SARS CoV-2 infection.
timeFrame: 3 months
Secondary outcomes:
measure: Incidence of hospital admissions caused by SARS-CoV-2 infection .
timeFrame: 3 months
measure: Incidence of ICU admissions caused by SARS-CoV-2 infection
timeFrame: 3 months
measure: Incidence of pneumonia caused by SARS-CoV-2 infection .
timeFrame: 3 months
measure: Incidence of need for oxygen support due to SARS-CoV-2 infection..
timeFrame: 3 months
measure: Incidence of gastrointestinal symptoms due to SARS-CoV-2 infection.
timeFrame: 3 months
measure: Days with body temperature> 37.5ºC.
timeFrame: 3 months
measure: Days of persistent cough.
timeFrame: 3 months
measure: Days of persistent feeling of fatigue.
timeFrame: 3 months
measure: Use of pharmacological treatments.
timeFrame: 3 months
measure: Serum levels of IgG antibody against SARS-CoV-2
timeFrame: 6-weeks from second dose of the vaccine
measure: Serum levels of IgA antibody against SARS-CoV-2
timeFrame: 6-weeks from second dose of the vaccine
Other outcomes:
Locations:
city: Santiago De Compostela
country: Spain
facility: Residencia San Marcos
state: A Coruña
city: Santiago De Compostela
country: Spain
facility: Residencia Santa Olalla
state: A Coruña
city: Santiago De Compostela
country: Spain
facility: Residencia San Simon de Ons
state: A Coruña
Study officials:
affiliation: Biosearch S.A.
name: Mónica Olivares, PhD
role: STUDY_DIRECTOR
affiliation: Complejo Hospitalario Universitario de Santiago Compostela
name: Anxo Fernandez-Ferreiro, PhD
role: PRINCIPAL_INVESTIGATOR
References: