Evaluation of the Probiotic Lactobacillus Coryniformis K8 on COVID-19 Prevention in Healthcare Workers
Multicentric Study to Assess the Effect of Consumption of Lactobacillus Coryniformis K8 on Healthcare Personnel Exposed to COVID-19
1 other identifier
interventional
314
1 country
1
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable covid19
Started Apr 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 24, 2020
CompletedFirst Submitted
Initial submission to the registry
April 27, 2020
CompletedFirst Posted
Study publicly available on registry
April 28, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2020
CompletedApril 30, 2020
April 1, 2020
1 month
April 27, 2020
April 28, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of SARS CoV-2 infection in healthcare workers
The incidence of SARS CoV-2 infection will be confirmed by PCR or antigen test
8 weeks
Secondary Outcomes (9)
Incidence of hospital admissions caused by SARS-CoV-2 infection
8 weeks
Incidence of ICU admissions caused by SARS-CoV-2 infection
8 weeks
Incidence of pneumonia caused by SARS-CoV-2 infection
8 weeks
Incidence of oxygen support requirement caused by SARS-CoV-2 infection
8 weeks
Incidence of gastrointestinal symptoms caused by SARS-CoV-2 infection
8 weeks
- +4 more secondary outcomes
Study Arms (2)
Probiotic
EXPERIMENTALExperimental group who will receive one capsule of Lactobacillus K8 per day (3x10\^9 cfu/day).
Control
PLACEBO COMPARATORControl group who will receive a daily placebo capsule consisting of maltodextrin
Interventions
Eligibility Criteria
You may qualify if:
- Persons over 20 years of age.
- Active healthcare personnel, who attend patients with COVID-19 disease, including all professional categories, medicine, nursing and warders.
- Ability to complete surveys.
- Signature of informed consent
You may not qualify if:
- Person with positive test of COVID-19 confirmed by PCR test or serology
- Person with concomitant pathology HIV, transplant, active oncology or other type of active immunosuppression
- Pregnant women or women with intention to become pregnant in the next 2 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biosearch S.A.lead
Study Sites (1)
Raquel Rodriguez Blanque
Granada, 18016, Spain
Related Publications (1)
Rodriguez-Blanque R, Sanchez-Garcia JC, Cobos Vargas A, Leyva Martinez MS, Martinez Diz S, Cortes-Martin J, Tovar-Galvez 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 Jun 28;12:e37857. doi: 10.2196/37857.
PMID: 37285326DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 27, 2020
First Posted
April 28, 2020
Study Start
April 24, 2020
Primary Completion
June 1, 2020
Study Completion
October 1, 2020
Last Updated
April 30, 2020
Record last verified: 2020-04
Data Sharing
- IPD Sharing
- Will not share