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

April 28, 2020 updated by: Biosearch S.A.

Multicentric Study to Assess the Effect of Consumption of Lactobacillus Coryniformis K8 on Healthcare Personnel Exposed to COVID-19

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 Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

314

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Probiotic
Experimental group who will receive one capsule of Lactobacillus K8 per day (3x10^9 cfu/day).
Dietary supplement: Probiotic
The probiotic group will received one capsule with Lactobacillus K8 per day (3x10^9 cfu/day) during 2 months
Placebo Comparator: Control
Control group who will receive a daily placebo capsule consisting of maltodextrin
Dietary supplement: Control
The control group will received one placebo capsule per day during 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of SARS CoV-2 infection in healthcare workers
Time Frame: 8 weeks
The incidence of SARS CoV-2 infection will be confirmed by PCR or antigen test
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of hospital admissions caused by SARS-CoV-2 infection
Time Frame: 8 weeks
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
8 weeks
Incidence of ICU admissions caused by SARS-CoV-2 infection
Time Frame: 8 weeks
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
8 weeks
Incidence of pneumonia caused by SARS-CoV-2 infection
Time Frame: 8 weeks
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
8 weeks
Incidence of oxygen support requirement caused by SARS-CoV-2 infection
Time Frame: 8 weeks
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
8 weeks
Incidence of gastrointestinal symptoms caused by SARS-CoV-2 infection
Time Frame: 8 weeks
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
8 weeks
Days with body's temperature > 37.5 ºC
Time Frame: 8 weeks
In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with body's temperature > 37.5 ºC during the course of the disease
8 weeks
Days with cough
Time Frame: 8 weeks
In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with cough during the course of the disease
8 weeks
Days with fatigue
Time Frame: 8 weeks
In the healthcare workers that confirm the SARS Cov-2 infection (primary variable), number of days with fatigue during the course of the disease
8 weeks
Medical treatment
Time Frame: 8 weeks
Use of drugs (dosis and duration of the treatment) for Covid-19 treatment
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biosearch S.A.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 24, 2020

Primary Completion (Anticipated)

June 1, 2020

Study Completion (Anticipated)

October 1, 2020

Study Registration Dates

First Submitted

April 27, 2020

First Submitted That Met QC Criteria

April 27, 2020

First Posted (Actual)

April 28, 2020

Study Record Updates

Last Update Posted (Actual)

April 30, 2020

Last Update Submitted That Met QC Criteria

April 28, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P054

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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