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

NCT ID: NCT04366180

Last Updated: 2020-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

314 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-04-24

Study Completion Date

2020-10-31

Brief Summary

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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

Detailed Description

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Conditions

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Covid-19

Keywords

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Covid-19 Prevention Healthcare workers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic

Experimental group who will receive one capsule of Lactobacillus K8 per day (3x10\^9 cfu/day).

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

The probiotic group will received one capsule with Lactobacillus K8 per day (3x10\^9 cfu/day) during 2 months

Control

Control group who will receive a daily placebo capsule consisting of maltodextrin

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

The control group will received one placebo capsule per day during 2 months

Interventions

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Probiotic

The probiotic group will received one capsule with Lactobacillus K8 per day (3x10\^9 cfu/day) during 2 months

Intervention Type DIETARY_SUPPLEMENT

Control

The control group will received one placebo capsule per day during 2 months

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Biosearch S.A.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Raquel Rodriguez Blanque

Granada, , Spain

Site Status RECRUITING

Countries

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Spain

Central Contacts

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Raquel Rodriguez Blanque

Role: CONTACT

Phone: +34 958 023 000

Email: [email protected]

Facility Contacts

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Raquel Rodriguez Blanque

Role: primary

References

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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.

Reference Type DERIVED
PMID: 37285326 (View on PubMed)

Other Identifiers

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P054

Identifier Type: -

Identifier Source: org_study_id