Covid19
Conditions
Brief 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. Participants will be randomized assigned to one of the two study groups: the control group with placebo consumption and a probiotic consumption group.
Interventions
DIETARY_SUPPLEMENTProbiotic: 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.
DIETARY_SUPPLEMENTPlacebo
Placebo in 1 capsule will be daily administrated during 28 days.
Sponsors
ProbiSearch SL
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus. | 1 month |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 1 month | Severity of symtoms will be analysed for fever (Tª\>38ºC) and gastrointestinal symptons (Bristol scale). |
| 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 | — |
Countries
Spain
Outcome results
None listed