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

ProbiSearch SL41 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Enrollment

Conditions

Covid19

Interventions

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Hospital Universitario Infanta Leonor

Madrid, Spain

Outcomes

Primary Outcomes

Concentration of specific IgM (Immunoglobulin M) and IgG (Immunoglobulin G) antibodies for the SARS-CoV-2 virus.

Time frame: 1 month

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

Severity of symtoms will be analysed for fever (Tª\>38ºC) and gastrointestinal symptons (Bristol scale).

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

Data from ClinicalTrials.gov

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