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Efficacy of L. Plantarum and P. Acidilactici in Adults With SARS-CoV-2 and COVID-19

NCT04517422 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2021-05-06

No results posted yet for this study

Summary

Clinical research focused to evaluate the effect as coadyuvant of a combination of L. plantarum and P. acidilactici in adults positive for SARS-CoV-2 with mild clinical COVID-19 symptoms. Main objective is to evaluate how this combination of probiotics reduce the risk to progress to moderate or severe COVID and associated advantages such as reduce the risk of death. Adittionnally this RCT is launching to explore the benefits of this combination of strains to modulate fecal microbiome and explore how this correlate with clinical improvement.

Conditions

  • SARS-CoV Infection

Interventions

DIETARY_SUPPLEMENT

Probiotics

Combination of Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT 7484, Lactobacillus plantarum CECT 7485, and Pediococcus acidilactici CECT 7483

OTHER

Placebo

Combination of maltodextrin (E1400, qs) in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0

Sponsors & Collaborators

  • Innovacion y Desarrollo de Estrategias en Salud

    collaborator OTHER

  • Hospital General Dr. Manuel Gea González

    collaborator OTHER_GOV

  • Hospital Angeles del Pedregal

    collaborator OTHER

  • AB Biotics, SA

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-19
Primary Completion
2021-02-02
Completion
2021-02-02

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04517422 on ClinicalTrials.gov