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

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.

Study Overview

• Status: Completed
• Conditions: Elderly; SARS CoV-2 Infection
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Lactobacillus

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 Type: Interventional
• Enrollment (Actual): 201
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • A Coruña
    • Santiago De Compostela, A Coruña, Spain, 15820
      • Residencia San Marcos
    • Santiago De Compostela, A Coruña, Spain, 15881
      • Residencia Santa Olalla
    • Santiago De Compostela, A Coruña, Spain, 15883
      • Residencia San Simon de Ons

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of SARS CoV-2 infection.	Incidence of SARS CoV-2 infection confirmed by PCR or antigen test	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Biosearch S.A.
• Investigators: Study Director: Mónica Olivares, PhD, Biosearch S.A.; Principal Investigator: Anxo Fernandez-Ferreiro, PhD, Complejo Hospitalario Universitario de Santiago Compostela

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): April 30, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: January 21, 2021
• First Submitted That Met QC Criteria: February 15, 2021
• First Posted (Actual): February 16, 2021

Study Record Updates

• Last Update Posted (Actual): October 21, 2024
• Last Update Submitted That Met QC Criteria: October 18, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: Probiotics; COVID19
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: P055

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No