Evaluation of Lactobacillus coryniformis K8 consumption by healthcare workers exposed to COVID-19 (LactoCor2 Project): Protocol for a randomised controlled trial.
JMIR Research Protocols 2023 April 13
BACKGROUND: Lactobacillus coryniformis K8 CECT5711 has immune modulating properties, enhances the immune response to viral antigens leading to the production of specific antibodies, has anti-inflammatory activity which may help to prevent uncontrolled inflammatory processes leading to respiratory and other organ failure.
OBJECTIVE: 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 Lactobacillus K8 per day (3x109 cfu/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: over 20 years of age, active health personnel caring for patients with COVID-19, including all professionals such as medical doctors, nurses and caretakers at the two referral hospitals that treat COVID-19 cases. 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 two referral hospitals that treat COVID-19 cases in the province of Granada (Andalusia, Spain); Hospital San Cecilio and Hospital Virgen de las Nieves. A total of 255 subjects met the inclusion criteria and were randomly assigned to one of the two groups.
CONCLUSIONS: The results of this RCT will provide valuable information regarding the administration of Lactobacillus 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 subjects taking the probiotic strain.
CLINICALTRIAL: Clinicaltrials.gov NCT04366180, https://clinicaltrials.gov/ct2/show/NCT04366180).
INTERNATIONAL REGISTERED REPORT: RR1-10.2196/37857.
OBJECTIVE: 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 Lactobacillus K8 per day (3x109 cfu/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: over 20 years of age, active health personnel caring for patients with COVID-19, including all professionals such as medical doctors, nurses and caretakers at the two referral hospitals that treat COVID-19 cases. 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 two referral hospitals that treat COVID-19 cases in the province of Granada (Andalusia, Spain); Hospital San Cecilio and Hospital Virgen de las Nieves. A total of 255 subjects met the inclusion criteria and were randomly assigned to one of the two groups.
CONCLUSIONS: The results of this RCT will provide valuable information regarding the administration of Lactobacillus 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 subjects taking the probiotic strain.
CLINICALTRIAL: Clinicaltrials.gov NCT04366180, https://clinicaltrials.gov/ct2/show/NCT04366180).
INTERNATIONAL REGISTERED REPORT: RR1-10.2196/37857.
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