Evaluation of Lactobacillus Coryniformis K8 Consumption by Health Care Workers Exposed to COVID-19 (LactoCor2 Project): Protocol for a Randomized Controlled Trial Rodríguez Blanque, Raquel Sánchez García, Juan Carlos Cobos Vargas, Ángel Leyva Martínez, Socorro Martínez Diz, Silvia Cortés Martín, Jonathan Tovar Gálvez, María Isabel COVID-19 Coronavirus Lactobacillus Health care workers Lactobacilos Trabajadores de la salud SARS-CoV-2 Probióticos Acknowledgments We thank all participants for their valuable contributions. We would especially like to thank the managing directors of the San Cecilio and Virgen de las Nieves University Hospitals. 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 (3×109 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. 2023-09-11T11:40:38Z 2023-09-11T11:40:38Z 2023-06-28 journal article Rodríguez-Blanque R, Sánchez-García JC, Cobos Vargas A, Leyva Martínez MS, Martínez Diz S, Cortés-Martín J, Tovar-Gálvez MI Evaluation of Lactobacillus Coryniformis K8 Consumption by Health Care Workers Exposed to COVID-19 (LactoCor2 Project): Protocol for a Randomized Controlled Trial JMIR Res Protoc 2023;12:e37857 [doi:10.2196/37857] https://hdl.handle.net/10481/84358 10.2196/37857 eng http://creativecommons.org/licenses/by/4.0/ open access Atribución 4.0 Internacional JMIR Publications