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Efficacy and Safety of L. Plantarum and P. Acidilactici in Children With Upper Respiratory Tract Infections

NCT05279534 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2023-10-17

No results posted yet for this study

Summary

Randomized, placebo-controlled trial to evaluate the coadjuvant effect of a combination of L. plantarum and P. acidilactici probiotic strains, taken twice daily, in children 6 months to 5 years-old with upper respiratory tract infections with pharyngitis and/or tonsillitis. Main objective is to evaluate efficacy of this probiotic in reducing fever and pain, as well to evaluate its safety.

Conditions

  • Upper Respiratory Tract Infections
  • Pharyngitis
  • Tonsillitis

Interventions

DIETARY_SUPPLEMENT

Probiotic

Combination of strains Lactobacillus plantarum CECT30292, Lactobacillus plantarum CECT7484, Lactobacillus plantarum CECT7485, and Pediococcus acidilactici CECT7483, twice daily for 15 days

OTHER

Placebo

Combination of maltodextrin (E1400, qs) in a vegetable hydroxymethylpropyl-cellulose capsule (HPMC) of size 0, twice daily for 15 days

Sponsors & Collaborators

  • Innovacion y Desarrollo de Estrategias en Salud

    collaborator OTHER

  • Hospital General Dr. Manuel Gea González

    collaborator OTHER_GOV

  • AB Biotics, SA

    lead INDUSTRY

Principal Investigators

  • Pedro Gutierrez-Castrellon, MD, PhD · Hospital General Dr. Manuel Gea Gonzalez

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Months
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-08
Primary Completion
2023-06-02
Completion
2023-06-02

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 NCT05279534 on ClinicalTrials.gov