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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04390477

Enrollment

Registered

2020-05-15

Start date

2020-05-04

Completion date

2021-04-30

Last updated

2022-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronavirus Infection, COVID-19

Keywords

Probiotic

Brief summary

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

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.

Interventions

DIETARY_SUPPLEMENTProbiotic

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Masking description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

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

Secondary

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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026