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Completed

NCT Number: NCT04756466

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.

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Key information

Conditions

SARS CoV-2 Infection COVID-19 Coronaviridae Infections Coronavirus Infections Elderly Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Residencia San Marcos, Santiago de Compostela, A Coruña, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Person over 60 years of age.
  • Intern in residence for the elderly.
  • Sign informed consent.

Exclusion criteria

  • Person who at some previous time has tested positive for detection of COVID-19 by PCR or serology.
  • Person who at the time of starting the intervention presents symptoms compatible with COVID-19.
  • Person with concomitant disease type HIV, transplant, active cancer or other type of active immunosuppression.

Treatment and study plan

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

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

Primary outcomes

  1. Incidence of SARS CoV-2 infection.

    Time frame: 3 months

    Incidence of SARS CoV-2 infection confirmed by PCR or antigen test

Secondary outcomes

  1. Incidence of hospital admissions caused by SARS-CoV-2 infection .

    Time frame: 3 months

    Incidence of hospital admissions caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test

  2. Incidence of ICU admissions caused by SARS-CoV-2 infection

    Time frame: 3 months

    Incidence of ICU admissions caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test

  3. Incidence of pneumonia caused by SARS-CoV-2 infection .

    Time frame: 3 months

    Incidence of pneumonia caused by infection caused by SARS-CoV-2 confirmed by PCR or antigen test

  4. Incidence of need for oxygen support due to SARS-CoV-2 infection..

    Time frame: 3 months

    Incidence of need for oxygen support due to SARS-CoV-2 infection confirmed by PCR or antigen test.

  5. Incidence of gastrointestinal symptoms due to SARS-CoV-2 infection.

    Time frame: 3 months

    Incidence of gastrointestinal symptoms due to SARS-CoV-2 infection confirmed by PCR or antigen test.

  6. Days with body temperature> 37.5ºC.

    Time frame: 3 months

    In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days with body temperature> 37.5ºC

  7. Days of persistent cough.

    Time frame: 3 months

    In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days with persistent cough

  8. Days of persistent feeling of fatigue.

    Time frame: 3 months

    In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days of persistent feeling of fatigue.

  9. Use of pharmacological treatments.

    Time frame: 3 months

    In case of SARS-CoV-2 infection confirmed by PCR or antigen test, use of pharmacological treatments

  10. Serum levels of IgG antibody against SARS-CoV-2

    Time frame: 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

  11. Serum levels of IgA antibody against SARS-CoV-2

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Biosearch S.A.

Industry

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 16, 2021
Registry last updated
Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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