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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | Placebo Comparator | Control group that will receive a daily placebo capsule consisting of maltodextrin during 3 months |
|
| Probiotic group | Experimental | Experimental group that will receive one capsule with the probiotic strain per day (3x10 9 CFU / day) during 3 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Dietary Supplement | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of SARS CoV-2 infection. | Incidence of SARS CoV-2 infection confirmed by PCR or antigen test | 3 months |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mónica Olivares, PhD | Biosearch S.A. | Study Director |
| Anxo Fernandez-Ferreiro, PhD | Complejo Hospitalario Universitario de Santiago Compostela | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Residencia San Marcos | Santiago de Compostela | A Coruña | 15820 | Spain | ||
| Residencia Santa Olalla |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C100843 | Lacteol |
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| Lactobacillus | Dietary Supplement | 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 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 |
| Santiago de Compostela |
| A Coruña |
| 15881 |
| Spain |
| Residencia San Simon de Ons | Santiago de Compostela | A Coruña | 15883 | Spain |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |