An interventional study of Placebo and Lactobacillus in SARS CoV-2 Infection and Elderly, sponsored by Biosearch S.A.. Completed at 3 sites in Spain. Open to participants aged 60 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-10-21.
Sponsored by Biosearch S.A. · Not applicable, Interventional, and Other
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.
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 201 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →Biosearch S.A. is the lead sponsor of 23 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Control group that will receive a daily placebo capsule consisting of maltodextrin during 3 months
Dietary Supplement: Placebo
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
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
Incidence of SARS CoV-2 infection.
Incidence of SARS CoV-2 infection confirmed by PCR or antigen test
Time frame: 3 months
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
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 3 months
Days of persistent cough.
In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days with persistent cough
Time frame: 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.
Time frame: 3 months
Use of pharmacological treatments.
In case of SARS-CoV-2 infection confirmed by PCR or antigen test, use of pharmacological treatments
Time frame: 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
Time frame: 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
Time frame: 6-weeks from second dose of the vaccine
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2024. You cannot join it, but the record below documents what was studied.
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Biosearch S.A.