Evaluation of a Probiotic Supplementation in the Immune Response of Participants With COVID-19 (Coronavirus Disease).
NCT ID: NCT04937556
Last Updated: 2022-05-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
41 participants
INTERVENTIONAL
2021-10-25
2022-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Probiotic: Lactobacillus salivarius + Vit D + Zinc
Lactobacillus strain during 28 days, approximately 1\*10E9 colony forming unit (CFU) of L. salivarius in 1 capsule per day.
Probiotic: Lactobacillus salivarius + Vit D + Zinc
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.
Placebo
Placebo supplement in 1 capsule per day during 28 days.
Placebo
Placebo in 1 capsule will be daily administrated during 28 days.
Interventions
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Probiotic: Lactobacillus salivarius + Vit D + Zinc
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.
Placebo
Placebo in 1 capsule will be daily administrated during 28 days.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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.
* 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.
18 Years
65 Years
ALL
No
Sponsors
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ProbiSearch SL
INDUSTRY
Responsible Party
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Locations
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Hospital Universitario Infanta Leonor
Madrid, , Spain
Countries
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Related Links
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Related Info
Other Identifiers
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COV/21.02
Identifier Type: -
Identifier Source: org_study_id
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