Evaluation of the Probiotic Lactobacillus Coryniformis K8 on COVID-19 Prevention in Healthcare Workers

Biosearch S.A.314 enrolled

Overview

The aim of the present study is to evaluate the effects of Lactobacillus coryniformis K8 consumption on the incidence and severity of Covid-19 in health workers exposed to the virus. This is a preventive study

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

314

Conditions

Covid-19

Interventions

ProbioticDIETARY_SUPPLEMENT

The probiotic group will received one capsule with Lactobacillus K8 per day (3x10\^9 cfu/day) during 2 months

ControlDIETARY_SUPPLEMENT

The control group will received one placebo capsule per day during 2 months

Eligibility

Sex: ALLMin age: 20 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: 1. Persons over 20 years of age. 2. Active healthcare personnel, who attend patients with COVID-19 disease, including all professional categories, medicine, nursing and warders. 3. Ability to complete surveys. 4. Signature of informed consent Exclusion Criteria: 1. Person with positive test of COVID-19 confirmed by PCR test or serology 2. Person with concomitant pathology HIV, transplant, active oncology or other type of active immunosuppression 3. Pregnant women or women with intention to become pregnant in the next 2 months.

Locations (1)

Raquel Rodriguez Blanque

Granada, Spain

RECRUITING

Outcomes

Primary Outcomes

Incidence of SARS CoV-2 infection in healthcare workers

The incidence of SARS CoV-2 infection will be confirmed by PCR or antigen test

Time frame: 8 weeks

Secondary Outcomes

Incidence of hospital admissions caused by SARS-CoV-2 infection

In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will required hospital admission because of Covid-19

Time frame: 8 weeks

Incidence of ICU admissions caused by SARS-CoV-2 infection

In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will required ICU admission because of Covid-19

Time frame: 8 weeks

Incidence of pneumonia caused by SARS-CoV-2 infection

In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will develop pneumonia because of Covid-19

Time frame: 8 weeks

Incidence of oxygen support requirement caused by SARS-CoV-2 infection

In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will require oxygen support because of Covid-19

Time frame: 8 weeks

Incidence of gastrointestinal symptoms caused by SARS-CoV-2 infection

In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), it will be evaluated how many of them will develop gastrointestinal symptoms because of Covid-19

Time frame: 8 weeks

Central Contacts

Raquel Rodriguez Blanque

CONTACT

+34 958 023 000 raquel.rodriguez.blanque.sspa@juntadeandalucia.es

Data from ClinicalTrials.gov

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