@Article{info:doi/10.2196/37857,
author="Rodr{\'i}guez-Blanque, Raquel
and S{\'a}nchez-Garc{\'i}a, Juan Carlos
and Cobos Vargas, Angel
and Leyva Mart{\'i}nez, M Socorro
and Mart{\'i}nez Diz, Silvia
and Cort{\'e}s-Mart{\'i}n, Jonathan
and Tovar-G{\'a}lvez, Mar{\'i}a Isabel",
title="Evaluation of Lactobacillus Coryniformis K8 Consumption by Health Care Workers Exposed to COVID-19 (LactoCor2 Project): Protocol for a Randomized Controlled Trial",
journal="JMIR Res Protoc",
year="2023",
month="Jun",
day="28",
volume="12",
pages="e37857",
keywords="COVID-19; coronavirus; Lactobacillus; health care workers; Lactobacilo; trabajadores de la salud; SARS-CoV-2; probi{\'o}tico",
abstract="Background: Lactobacillus coryniformis K8 CECT5711 has immune-modulating properties, enhances the immune response to viral antigens leading to the production of specific antibodies, and has anti-inflammatory activity, which may help to prevent uncontrolled inflammatory processes leading to respiratory and other organ failures. Objective: The purpose of this study is to evaluate the effect of the consumption of a probiotic strain on the incidence and severity of COVID-19 in health personnel who carry out their professional work among patients with infection or suspected infection by SARS-CoV-2. Methods: This is a double-blind randomized clinical trial in which the experimental group will receive a capsule of L coryniformis K8 per day (3{\texttimes}109 colony former units/day), and the control group will receive a daily placebo capsule consisting of maltodextrin. A sample size of 314 volunteers was calculated. Volunteers must meet the following inclusion criteria: older than 20 years and active health personnel caring for patients with COVID-19, including all professionals such as medical doctors, nurses, and caretakers at the 2 referral hospitals that treat patients with COVID-19. The main outcome of the clinical trial will be the incidence of symptomatic infection by SARS-CoV-2 in personnel who care for patients with suspected or confirmed COVID-19. Results: The study had to be extended to the 2 referral hospitals that treat patients with COVID-19 in the province of Granada (Andalusia, Spain); Hospital San Cecilio and Hospital Virgen de las Nieves. A total of 255 individuals met the inclusion criteria and were randomly assigned to one of the 2 groups. Conclusions: The results of this randomized controlled trial will provide valuable information regarding the administration of L coryniformis K8 against COVID-19, including whether there are fewer infectious processes due to this virus or, in case of occurrence, whether the disease is milder in participants taking the probiotic strain. Trial Registration: ClinicalTrials.gov NCT04366180; http://www.clinicaltrials.gov/ct2/show/NCT04366180 International Registered Report Identifier (IRRID): RR1-10.2196/37857 ",
issn="1929-0748",
doi="10.2196/37857",
url="https://www.researchprotocols.org/2023/1/e37857",
url="https://doi.org/10.2196/37857",
url="http://www.ncbi.nlm.nih.gov/pubmed/372853"
}