SARS CoV-2 InfectionNCT04756466
Effect of the Consumption of a Lactobacillus Strain on the Incidence of Covid-19 in the Elderly
A study testing Lactobacillus in people with SARS CoV-2 Infection and Elderly, run by Biosearch S.A. at 3 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- SARS CoV-2 Infection, Elderly
- What is being tested?
- Lactobacillus
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Jan 2021to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Person over 60 years of age.
- Intern in residence for the elderly.
- Sign informed consent.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
Spain3 sites
Residencia San Marcos
Santiago de Compostela, A Coruña, 15820
Residencia Santa Olalla
Santiago de Compostela, A Coruña, 15881
Residencia San Simon de Ons
Santiago de Compostela, A Coruña, 15883
About this study
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
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.
Read the 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.
- Conditions
- SARS CoV-2 Infection, Elderly
- Being tested
- Placebo, Lactobacillus
- Keywords
- Probiotics, COVID19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary 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
LactobacillusDietary 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
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | Control group that will receive a daily placebo capsule consisting of maltodextrin during 3 months Receives: Dietary Supplement: Placebo |
| Probiotic group | Experimental | Experimental group that will receive one capsule with the probiotic strain per day (3x10 9 CFU / day) during 3 months Receives: Dietary Supplement: Lactobacillus |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SARS CoV-2 infection.
Incidence of SARS CoV-2 infection confirmed by PCR or antigen test
Measured: 3 months
Secondary outcomes (11)
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
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months
Days of persistent cough.
In case of SARS-CoV-2 infection confirmed by PCR or antigen test, Days with persistent cough
Measured: 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.
Measured: 3 months
Use of pharmacological treatments.
In case of SARS-CoV-2 infection confirmed by PCR or antigen test, use of pharmacological treatments
Measured: 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
Measured: 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
Measured: 6-weeks from second dose of the vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2021
- Study start1 Jan 2021
- Primary completion30 Apr 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV-2 InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Mónica Olivares, PhD, Study director, Biosearch S.A.Anxo Fernandez-Ferreiro, PhD, Principal investigator, Complejo Hospitalario Universitario de Santiago Compostela
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04756466
- Sponsor's protocol ID
- P055
- Status last verified
- Oct 2024
- First submitted
- 21 Jan 2021
- Last updated
- 21 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04756466
- Acronym / sponsor ID
- P055
- Conditions
- SARS CoV-2 Infection, Elderly
- Keywords
- Probiotics, COVID19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 16 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Dietary Supplement: PlaceboControl group that will receive a daily placebo capsule consisting of maltodextrin during 3 months |
| Probiotic group | Experimental | Dietary Supplement: LactobacillusExperimental group that will receive one capsule with the probiotic strain per day (3x10 9 CFU / day) during 3 months |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Person over 60 years of age.
- Intern in residence for the elderly.
- Sign informed consent.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboEach participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits | Dietary supplement | Control group |
| LactobacillusEach participant will consume 1 capsule per day in one of the main meals without any restriction in the diet or in their life habits | Dietary supplement | Probiotic group |
Primary outcome
Incidence of SARS CoV-2 infection.
Time frame: 3 months
Incidence of SARS CoV-2 infection confirmed by PCR or antigen test
11 secondary outcomes
Incidence of hospital admissions caused by SARS-CoV-2 infection .
Time frame: 3 months
Incidence of ICU admissions caused by SARS-CoV-2 infection
Time frame: 3 months
Incidence of pneumonia caused by SARS-CoV-2 infection .
Time frame: 3 months
Incidence of need for oxygen support due to SARS-CoV-2 infection..
Time frame: 3 months
Incidence of gastrointestinal symptoms due to SARS-CoV-2 infection.
Time frame: 3 months
Days with body temperature> 37.5ºC.
Time frame: 3 months
Days of persistent cough.
Time frame: 3 months
Days of persistent feeling of fatigue.
Time frame: 3 months
Use of pharmacological treatments.
Time frame: 3 months
Serum levels of IgG antibody against SARS-CoV-2
Time frame: 6-weeks from second dose of the vaccine
Serum levels of IgA antibody against SARS-CoV-2
Time frame: 6-weeks from second dose of the vaccine
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mónica Olivares, PhD study director
Biosearch S.A.
Anxo Fernandez-Ferreiro, PhD principal investigator
Complejo Hospitalario Universitario de Santiago Compostela
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lactobacillus in people with SARS CoV-2 Infection and Elderly, run by Biosearch S.A. at 3 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of SARS CoV-2 infection. (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2024.