Skip to main content
OpenTrials
Completed

NCT Number: NCT04390477

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infection Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitario del Vinalopó, Elche, Alicante, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Probiotic

Dietary Supplement

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

Primary outcomes

  1. Cases with discharge to ICU.

    Time frame: 30-days

    Percentage of patients with discharge to ICU.

  2. Patients with resolution of digestive symptoms

    Time frame: 30 days

    Percentage of patients with improvement between the initial and final visits

Secondary outcomes

  1. Patients with home discharge.

    Time frame: 30-days

    Percentage of patients with home discharge.

  2. Mortality.

    Time frame: 30-days

    Percentage of deaths.

  3. 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.

  4. 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.

  5. 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.

  6. Patients with resolution of non-digestive symptoms

    Time frame: 30 days

    Percentage of patients with improvement between the initial and final visits

Sponsors and collaborators

Lead sponsor

Bioithas SL

Industry

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
May 15, 2020
Registry last updated
Apr 29, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.