A Study to Investigate the Effect of Probiotics (L. Reuteri ATCC PTA 5289 and L. Reuteri DSM 17938) on Symptoms of Viral Upper Respiratory Tract Infections in Children

Last updated: January 11, 2024
Sponsor: Milosevits Gergely
Overall Status: Active - Recruiting

Phase

N/A

Condition

Respiratory Syncytial Virus (Rsv) Infection

Treatment

Placebo

BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)

Clinical Study ID

NCT06205966
SzentMiklósSzolgálatKft.
  • Ages 4-17
  • All Genders

Study Summary

This study investigates the effect of Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) on symptoms of viral upper-respiratory tract infections in children.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Children with symptoms of upper respiratory tract infection (coughing/fever/sneezing/runny or congested nose/pharynx pain)
  • Any gender
  • Age from 4 years to 17 years
  • Signing a informed consent form by at least one parent, foster parent or guardianafter patient information and by children aged over 6 years
  • Negative Strep test

Exclusion

Exclusion Criteria:

  • Use of antibiotics or probiotics in the 10 days prior to study enrolment
  • Use of a probiotic other than the test sample during the study
  • Eight or more otitis media within 12 months
  • Two or more bacterial sinusitis within 12 months
  • Two or more pneumonia episodes within 12 months
  • History of two or more invasive infections (meningitis, cellulitis, osteomyelitis,septicaemia)
  • Chronic diarrhea
  • Recurrent deep skin or organ abscesses
  • Persistent superficial candidiasis
  • Use of antibiotics for two months or more to treat respiratory infections within 12months
  • Gastroesophageal reflux
  • Perennial (e.g., dust mite or mold) or current seasonal hay fever allergy
  • Primary or secondary ciliary dyskinesia
  • Congenital malformations of the respiratory tract

Study Design

Total Participants: 142
Treatment Group(s): 2
Primary Treatment: Placebo
Phase:
Study Start date:
December 21, 2023
Estimated Completion Date:
November 30, 2025

Study Description

Lactobacillus reuteri probiotic strains (ATCC PTA 5289 and DSM 17938) have been shown to significantly reduce the number of febrile days and pain severity in upper respiratory tract infections in children aged six months to 5 years. The investigator's planned study complements this earlier publication by significantly increasing the number of cases and expanding the age range studied including children from 4 to 17 years of age diagnosed with viral upper respiratory-tract infection.

Connect with a study center

  • Szent Miklós Szolgálat Kft.

    Szigetszentmiklós, Pest 2310
    Hungary

    Active - Recruiting

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