Evaluation of a Probiotic Supplementation in the Immune Response of Participants With COVID-19 (Coronavirus Disease).

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Covid19

Intervention / Treatment
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* Dietary Supplement: Probiotic: Lactobacillus salivarius + Vit D + Zinc
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Probiotic: Lactobacillus salivarius + Vit D + Zinc<br>Lactobacillus strain during 28 days, approximately 1*10E9 colony forming unit (CFU) of L. salivarius in 1 capsule per day. | Dietary Supplement: Probiotic: Lactobacillus salivarius + Vit D + Zinc<br>* 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.<br>|
| Placebo Comparator: Placebo<br>Placebo supplement in 1 capsule per day during 28 days. | Dietary Supplement: Placebo<br>* Placebo in 1 capsule will be daily administrated during 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus. |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels (pg/ml) of pro-inflammatory and anti-inflammatory markers in blood serum. |  | 1 month | 
| Duration of the symptoms produced by the SARS-CoV-2 infection |  | 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). | 1 month | 
| Percentage of participants with a negative result in the SARS-CoV-2 detection test by PCR (Polymerase Chain Reaction) at visit 2 |  | 1 month | 
| Percentage of participants with worsening of lower respiratory tract infections |  | 1 month |