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

Not Applicable

Completed

• Conditions: SARS CoV-2 Infection; Elderly
• Interventions: Dietary Supplement: Lactobacillus; Dietary Supplement: Placebo

• Registration Number: NCT04756466
• Lead Sponsor: Biosearch S.A.

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.

Study Timeline

• Study Start: 2021-01-01
• Study First Submitted: 2021-01-21
• Study First Submitted QC: 2021-02-15
• Study First Posted: 2021-02-16
• Primary Completion: 2021-04-30
• Study Completion: 2021-12-31
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-18
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 201

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic group	Lactobacillus	Experimental group that will receive one capsule with the probiotic strain per day (3x10 9 CFU / day) during 3 months
Control group	Placebo	Control group that will receive a daily placebo capsule consisting of maltodextrin during 3 months

Primary Outcome Measures

Name	Time	Method
Incidence of SARS CoV-2 infection.	3 months	Incidence of SARS CoV-2 infection confirmed by PCR or antigen test

Secondary Outcome Measures

Name	Time	Method
Serum levels of IgG antibody against SARS-CoV-2	6-weeks from second dose of the vaccine	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
Use of pharmacological treatments.	3 months	In case of SARS-CoV-2 infection confirmed by PCR or antigen test, use of pharmacological treatments
Incidence of need for oxygen support due to SARS-CoV-2 infection..	3 months	Incidence of need for oxygen support due to SARS-CoV-2 infection confirmed by PCR or antigen test.
Days of persistent feeling of fatigue.	3 months	In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days of persistent feeling of fatigue.
Incidence of hospital admissions caused by SARS-CoV-2 infection .	3 months	Incidence of hospital admissions caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test
Incidence of ICU admissions caused by SARS-CoV-2 infection	3 months	Incidence of ICU admissions caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test
Serum levels of IgA antibody against SARS-CoV-2	6-weeks from second dose of the vaccine	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
Incidence of pneumonia caused by SARS-CoV-2 infection .	3 months	Incidence of pneumonia caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test
Days with body temperature> 37.5ºC.	3 months	In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days with body temperature\> 37.5ºC
Incidence of gastrointestinal symptoms due to SARS-CoV-2 infection.	3 months	Incidence of gastrointestinal symptoms due to SARS-CoV-2 infection confirmed by PCR or antigen test.
Days of persistent cough.	3 months	In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days with persistent cough

Trial Locations

Locations (3)

Residencia Santa Olalla; 🇪🇸 Santiago De Compostela, A Coruña, Spain

Residencia San Simon de Ons; 🇪🇸 Santiago De Compostela, A Coruña, Spain

Residencia San Marcos; 🇪🇸 Santiago De Compostela, A Coruña, Spain