Study to Evaluate the Effect of a Probiotic in COVID-19

NCT ID: NCT04390477

Last Updated: 2022-04-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-04

Study Completion Date

2021-04-30

Brief Summary

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A prospective case-control pilot study to evaluate the possible effect of a probiotic mixture in the improvement of symptoms, the reduction in the number of days of hospitalization and the increase in the percentage of patients with negative PCR after infection with the coronavirus SARS-CoV-2.

Detailed Description

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In this study, the investigators hypothesize a positive effect of probiotic on the gut microbiome that could led to produce a less severe clinical evolution of the disease.

Conditions

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COVID-19 Coronavirus Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Random numbers table. One branch placebo and other one no intervention

Study Groups

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Probiotic

1 pill od containing 1x10E9 cfu of the probiotic

Group Type EXPERIMENTAL

Probiotic

Intervention Type DIETARY_SUPPLEMENT

Oral daily capsule containing probiotic strains with maltodextrin as excipient, administrated for 30 days.

Control

No treatment

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Probiotic

Oral daily capsule containing probiotic strains with maltodextrin as excipient, administrated for 30 days.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Patients with a confirmed diagnosis of SARS-Cov.2 infection using the PCR and that require admission to the hospitalization area.

Exclusion Criteria

* Inability or refusal to sign informed consent.
* Allergy or intolerance to the intervention product or its components.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bioithas SL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Vicente Navarro

Role: PRINCIPAL_INVESTIGATOR

Hospital universitario del Vinalopo, Elche, Spain

Locations

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Hospital Universitario del Vinalopó

Elche, Alicante, Spain

Site Status

Hospital Universitario de Torrevieja

Torrevieja, Alicante, Spain

Site Status

Countries

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Spain

Other Identifiers

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COVID.PROB

Identifier Type: -

Identifier Source: org_study_id

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