Covid-19NCT04366180
Evaluation of the Probiotic Lactobacillus Coryniformis K8 on COVID-19 Prevention in Healthcare Workers
A study testing Probiotic in people with Covid-19, run by Biosearch S.A. at 1 site in Spain.
Trial summary
The aim of the present study is to evaluate the effects of Lactobacillus coryniformis K8 consumption on the incidence and severity of Covid-19 in health workers exposed to the virus. This is a preventive study Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Covid-19
- What is being tested?
- Probiotic
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 255 participants
- Where
- 1 siteSpain
- Study dates
- 24 Apr 2020to 11 Jul 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 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Persons over 20 years of age.
- Active healthcare personnel, who attend patients with COVID-19 disease, including all professional categories, medicine, nursing and warders.
- Ability to complete surveys.
- Signature of informed consent
Who cannot join
- Person with positive test of COVID-19 confirmed by PCR test or serology
- Person with concomitant pathology HIV, transplant, active oncology or other type of active immunosuppression
- Pregnant women or women with intention to become pregnant in the next 2 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Multicentric Study to Assess the Effect of Consumption of Lactobacillus Coryniformis K8 on Healthcare Personnel Exposed to COVID-19
The aim of the present study is to evaluate the effects of Lactobacillus coryniformis K8 consumption on the incidence and severity of Covid-19 in health workers exposed to the virus. This is a preventive study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
The probiotic group will received one capsule with Lactobacillus K8 per day (3x10^9 cfu/day) during 2 months
ControlDietary supplement
The control group will received one placebo capsule per day during 2 months
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Experimental | Experimental group who will receive one capsule of Lactobacillus K8 per day (3x10^9 cfu/day). Receives: Dietary Supplement: Probiotic |
| Control | Placebo comparator | Control group who will receive a daily placebo capsule consisting of maltodextrin Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of SARS CoV-2 infection in healthcare workers
The incidence of SARS CoV-2 infection will be confirmed by PCR or antigen test
Measured: 8 weeks
Secondary outcomes (9)
Incidence of hospital admissions caused by SARS-CoV-2 infection
In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will required hospital admission because of Covid-19
Measured: 8 weeks
Incidence of ICU admissions caused by SARS-CoV-2 infection
In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will required ICU admission because of Covid-19
Measured: 8 weeks
Incidence of pneumonia caused by SARS-CoV-2 infection
In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will develop pneumonia because of Covid-19
Measured: 8 weeks
Incidence of oxygen support requirement caused by SARS-CoV-2 infection
In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will require oxygen support because of Covid-19
Measured: 8 weeks
Incidence of gastrointestinal symptoms caused by SARS-CoV-2 infection
In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will develop gastrointestinal symptoms because of Covid-19
Measured: 8 weeks
Days with body's temperature > 37.5 ºC
In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with body's temperature > 37.5 ºC during the course of the disease
Measured: 8 weeks
Days with cough
In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with cough during the course of the disease
Measured: 8 weeks
Days with fatigue
In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with fatigue during the course of the disease
Measured: 8 weeks
Medical treatment
Use of drugs (dosis and duration of the treatment) for Covid-19 treatment
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2020
- Study start24 Apr 2020
- Primary completion11 Jul 2021
- Study completion11 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Covid-19Studies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biosearch S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04366180
- Sponsor's protocol ID
- P054
- Status last verified
- Apr 2020
- First submitted
- 27 Apr 2020
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rodriguez-Blanque R, Sanchez-Garcia JC, Cobos Vargas A, Leyva Martinez MS, Martinez Diz S, Cortes-Martin J, Tovar-Galvez MI. Evaluation of Lactobacillus Coryniformis K8 Consumption by Health Care Workers Exposed to COVID-19 (LactoCor2 Project): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 28;12:e37857. doi: 10.2196/37857.
PubMed 37285326
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Study to Assess the Effect of Consumption of Lactobacillus Coryniformis K8 on Healthcare Personnel Exposed to COVID-19
- ClinicalTrials.gov ID
- NCT04366180
- Acronym / sponsor ID
- P054
- Conditions
- Covid-19
- Keywords
- Covid-19, Prevention, Healthcare workers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Biosearch S.A.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2020 (actual)
- Primary completion
- 11 Jul 2021 (actual)
- Study completion
- 11 Jul 2021 (actual)
- First posted
- 28 Apr 2020 (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 aim of the present study is to evaluate the effects of Lactobacillus coryniformis K8 consumption on the incidence and severity of Covid-19 in health workers exposed to the virus. This is a preventive study
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Experimental | Dietary Supplement: ProbioticExperimental group who will receive one capsule of Lactobacillus K8 per day (3x10^9 cfu/day). |
| Control | Placebo comparator | Dietary Supplement: ControlControl group who will receive a daily placebo capsule consisting of maltodextrin |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Persons over 20 years of age.
- Active healthcare personnel, who attend patients with COVID-19 disease, including all professional categories, medicine, nursing and warders.
- Ability to complete surveys.
- Signature of informed consent
Key exclusion criteria (3 listed)
- Person with positive test of COVID-19 confirmed by PCR test or serology
- Person with concomitant pathology HIV, transplant, active oncology or other type of active immunosuppression
- Pregnant women or women with intention to become pregnant in the next 2 months.
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 |
|---|---|---|
| ProbioticThe probiotic group will received one capsule with Lactobacillus K8 per day (3x10^9 cfu/day) during 2 months | Dietary supplement | Probiotic |
| ControlThe control group will received one placebo capsule per day during 2 months | Dietary supplement | Control |
Primary outcome
Incidence of SARS CoV-2 infection in healthcare workers
Time frame: 8 weeks
The incidence of SARS CoV-2 infection will be confirmed by PCR or antigen test
9 secondary outcomes
Incidence of hospital admissions caused by SARS-CoV-2 infection
Time frame: 8 weeks
Incidence of ICU admissions caused by SARS-CoV-2 infection
Time frame: 8 weeks
Incidence of pneumonia caused by SARS-CoV-2 infection
Time frame: 8 weeks
Incidence of oxygen support requirement caused by SARS-CoV-2 infection
Time frame: 8 weeks
Incidence of gastrointestinal symptoms caused by SARS-CoV-2 infection
Time frame: 8 weeks
Days with body's temperature > 37.5 ºC
Time frame: 8 weeks
Days with cough
Time frame: 8 weeks
Days with fatigue
Time frame: 8 weeks
Medical treatment
Time frame: 8 weeks
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 6 Oct 2026.
- Derived from this study: PubMed 37285326Rodriguez-Blanque R, Sanchez-Garcia JC, Cobos Vargas A, Leyva Martinez MS, Martinez Diz S, Cortes-Martin J, Tovar-Galvez MI. Evaluation of Lactobacillus Coryniformis K8 Consumption by Health Care Workers Exposed to COVID-19 (LactoCor2 Project): Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 Jun 28;12:e37857. doi: 10.2196/37857.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Covid-19, run by Biosearch S.A. at 1 site 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 4 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 in healthcare workers (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04366180, which also lists 1 linked publication.
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 6 Oct 2026.