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

Elderly Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04756466
• Other study ID #: P055
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: December 31, 2021

Study information

• Verified date: March 2021
• Source: Biosearch S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 201
• Est. completion date: December 31, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Elderly
• SARS CoV-2 Infection

Intervention

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
• 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

Locations

Country	Name	City	State
Spain	Residencia San Marcos	Santiago De Compostela	A Coruña
Spain	Residencia San Simon de Ons	Santiago De Compostela	A Coruña
Spain	Residencia Santa Olalla	Santiago De Compostela	A Coruña

Sponsors (1)

Lead Sponsor	Collaborator
Biosearch S.A.

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of SARS CoV-2 infection.	Incidence of SARS CoV-2 infection confirmed by PCR or antigen test	3 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Days of persistent cough.	In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days with persistent cough	3 months
Secondary	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
Secondary	Use of pharmacological treatments.	In case of SARS-CoV-2 infection confirmed by PCR or antigen test, use of pharmacological treatments	3 months
Secondary	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
Secondary	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