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

April 25, 2022 updated by: Bioithas SL

The Intestinal Microbiota as a Therapeutic Target in Hospitalized Patients With COVID-19 Infection

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

41

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

  • Spain
    • Alicante
      • Elche, Alicante, Spain, 03293
        • Hospital Universitario del Vinalopó
      • Torrevieja, Alicante, Spain, 03198
        • Hospital Universitario de Torrevieja

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Probiotic
1 pill od containing 1x10E9 cfu of the probiotic
Dietary supplement: Probiotic
Oral daily capsule containing probiotic strains with maltodextrin as excipient, administrated for 30 days.
NO_INTERVENTION: Control
No treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cases with discharge to ICU.
Time Frame: 30-days
Percentage of patients with discharge to ICU.
30-days
Patients with resolution of digestive symptoms
Time Frame: 30 days
Percentage of patients with improvement between the initial and final visits
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients with home discharge.
Time Frame: 30-days
Percentage of patients with home discharge.
30-days
Mortality.
Time Frame: 30-days
Percentage of deaths.
30-days
Treatment safety assessed by number of adverse events.
Time Frame: 30-days
Number of adverse events that occur during the treatment period, attributable or not to the intervention product.
30-days
New cases of SARS-Cov-2 infection among healthcare personnel caring for the patients.
Time Frame: 30-days
Number of new cases of positive SARS-Cov-2 infection by PCR analysis.
30-days
Patients with negative PCR and/or Antigen test result for SARS-CoV-2 infection.
Time Frame: 10-15 days
Percentage of patients with negative test for SARS-CoV-2.
10-15 days
Patients with resolution of non-digestive symptoms
Time Frame: 30 days
Percentage of patients with improvement between the initial and final visits
30 days

Collaborators and Investigators

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

Sponsor

Bioithas SL

Investigators

  • Principal Investigator: Vicente Navarro, Hospital universitario del Vinalopo, Elche, Spain

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)

May 4, 2020

Primary Completion (ACTUAL)

March 21, 2021

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

May 7, 2020

First Submitted That Met QC Criteria

May 14, 2020

First Posted (ACTUAL)

May 15, 2020

Study Record Updates

Last Update Posted (ACTUAL)

April 29, 2022

Last Update Submitted That Met QC Criteria

April 25, 2022

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COVID.PROB

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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