Covid19PROVIDNCT04937556
Evaluation of a Probiotic Supplementation in the Immune Response of Participants With COVID-19 (Coronavirus Disease).
A study testing Probiotic: Lactobacillus salivarius + Vit D + Zinc in people with Covid19, run by ProbiSearch SL at 1 site in Spain.
Trial summary
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strain on the immune response in participants positive for SARS-CoV-2 infection. The study duration will be 28 days, which includes 4 weeks product administration. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- Probiotic: Lactobacillus salivarius + Vit D + Zinc
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 41 participants
- Where
- 1 siteSpain
- Study dates
- 25 Oct 2021to 30 Apr 2022
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (18-65 years).
- Mild infection by SARS-CoV-2 detected by PCR or Antigen.
- Onset of COVID-19 symptoms up to 5 days before the day of inclusion
- Without hospitalization or oxygen supplementation on the day of inclusion.
- Signed written informed consent
Who cannot join
- Serious SARS-CoV-2 infection requiring hospitalization or oxygen supply
- Chronic diseases under regular medication (eg asthma, allergic rhinitis ...)
- Congenital or acquired immunodeficiency
- Body Mass Index (BMI)> 30
- Coagulation disorders
- Short bowel syndrome or any surgery on the gastrointestinal tract.
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- Metabolic disorders (diabetes, etc.).
- Heart failure and cardiac medical history
- Pregnant women.
- HIV positive.
- Immunocompromised
- History of significant gastrointestinal diseases
- Use of other probiotics during the last month.
- Uncertainty about the willingness or ability of the participant to comply with the requirements of the protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of the Lactobacillus Probiotic Strain in the Immune Response in Participants Positive for SARS-CoV-2 (Severe Acute Respiratory Syndrome-Coronavirus-2) Infection.
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strain on the immune response in participants positive for SARS-CoV-2 infection.
The study duration will be 28 days, which includes 4 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.
- Conditions
- Covid19
- Being tested
- Probiotic: Lactobacillus salivarius + Vit D + Zinc, Placebo
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Probiotic: Lactobacillus salivarius + Vit D + ZincDietary supplement
A mixture of 1*10E9 colony forming unit (CFU) of Lactobacillus salivarius + Vit D + Zinc citrate in 1 capsule will be daily administrated during 28 days.
PlaceboDietary supplement
Placebo in 1 capsule will be daily administrated during 28 days.
| Study group | Role | What they receive |
|---|---|---|
| Probiotic: Lactobacillus salivarius + Vit D + Zinc | Active comparator | Lactobacillus strain during 28 days, approximately 1*10E9 colony forming unit (CFU) of L. salivarius in 1 capsule per day. Receives: Dietary Supplement: Probiotic: Lactobacillus salivarius + Vit D + Zinc |
| Placebo | Placebo comparator | Placebo supplement in 1 capsule per day during 28 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus.
Measured: 1 month
Secondary outcomes (5)
Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood serum.
Measured: 1 month
Duration of the symptoms produced by the SARS-CoV-2 infection
Measured: 1 month
Severity of symptoms produced during SARS-CoV-2 infection
Severity of symtoms will be analysed for fever (Tª>38ºC) and gastrointestinal symptons (Bristol scale).
Measured: 1 month
Percentage of participants with a negative result in the SARS-CoV-2 detection test by PCR (Polymerase Chain Reaction) at visit 2
Measured: 1 month
Percentage of participants with worsening of lower respiratory tract infections
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2021
- Study start25 Oct 2021
- Primary completion25 Mar 2022
- Study completion30 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProbiSearch SL
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04937556
- Sponsor's protocol ID
- COV/21.02
- Acronym
- PROVID
- Status last verified
- Apr 2022
- First submitted
- 14 Jun 2021
- Last updated
- 31 May 2022
- Results posted
- No
- 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 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of the Lactobacillus Probiotic Strain in the Immune Response in Participants Positive for SARS-CoV-2 (Severe Acute Respiratory Syndrome-Coronavirus-2) Infection.
- ClinicalTrials.gov ID
- NCT04937556
- Acronym / sponsor ID
- PROVID / COV/21.02
- Conditions
- Covid19
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- ProbiSearch SLIndustry (pharma, biotech, devices)
- Study start
- 25 Oct 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 30 Apr 2022 (actual)
- First posted
- 24 Jun 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.
An interventional, randomized, double-blind, placebo-controlled study will be conducted to investigate the effect of a probiotic strain on the immune response in participants positive for SARS-CoV-2 infection.
The study duration will be 28 days, which includes 4 weeks product administration. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Probiotic: Lactobacillus salivarius + Vit D + Zinc | Active comparator | Dietary Supplement: Probiotic: Lactobacillus salivarius + Vit D + ZincLactobacillus strain during 28 days, approximately 1*10E9 colony forming unit (CFU) of L. salivarius in 1 capsule per day. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPlacebo supplement in 1 capsule per day during 28 days. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult (18-65 years).
- Mild infection by SARS-CoV-2 detected by PCR or Antigen.
- Onset of COVID-19 symptoms up to 5 days before the day of inclusion
- Without hospitalization or oxygen supplementation on the day of inclusion.
- Signed written informed consent
Key exclusion criteria (14 listed)
- Serious SARS-CoV-2 infection requiring hospitalization or oxygen supply
- Chronic diseases under regular medication (eg asthma, allergic rhinitis ...)
- Congenital or acquired immunodeficiency
- Body Mass Index (BMI)> 30
- Coagulation disorders
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 |
|---|---|---|
| Probiotic: Lactobacillus salivarius + Vit D + ZincA mixture of 1*10E9 colony forming unit (CFU) of Lactobacillus salivarius + Vit D + Zinc citrate in 1 capsule will be daily administrated during 28 days. | Dietary supplement | Probiotic: Lactobacillus salivarius + Vit D + Zinc |
| PlaceboPlacebo in 1 capsule will be daily administrated during 28 days. | Dietary supplement | Placebo |
Primary outcome
Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus.
Time frame: 1 month
5 secondary outcomes
Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood serum.
Time frame: 1 month
Duration of the symptoms produced by the SARS-CoV-2 infection
Time frame: 1 month
Severity of symptoms produced during SARS-CoV-2 infection
Time frame: 1 month
Percentage of participants with a negative result in the SARS-CoV-2 detection test by PCR (Polymerase Chain Reaction) at visit 2
Time frame: 1 month
Percentage of participants with worsening of lower respiratory tract infections
Time frame: 1 month
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 31 May 2022.
- Related InfoLink provided by the sponsor.
- 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: Lactobacillus salivarius + Vit D + Zinc in people with Covid19, run by ProbiSearch SL 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 5 inclusion and 14 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 31 May 2022. 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?
Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus. (time frame: 1 month). 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 31 May 2022.