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

January 11, 2024 updated by: Milosevits Gergely

A Randomized, Double Blind, Placebo-controlled 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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Estimated)

142

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
    • Pest
      • Szigetszentmiklós, Pest, Hungary, 2310
        • Recruiting
        • Szent Miklós Szolgálat Kft.
        • Contact:
        • Principal Investigator:
          • Gergely Milosevits, M.D., PhD.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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 guardian after patient information and by children aged over 6 years
  • Negative Strep test

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 12 months
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Probiotics
Study product containing L. reuteri (PTA5289 and DSM 17938) taken orally once in the morning and once in the evening, each time 5 drops.
Dietary supplement: BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)
BioGaia Pharax drops (with PTA5289 and DSM 17938) with vitamin D3 will be manufactured and delivered by BioGaia AB as oil suspension.
Placebo Comparator: Placebo
Placebo taken orally once in the morning and once in the evening, each time 5 drops.
Other: Placebo
Placebo product contains vitamin D3 and is identical to the active product but lacks L. reuteri.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Time to healing, defined as number of hours until absence of symptoms (fever, runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) as well as absence of use of Non-steroidal anti-inflammatory drugs (NSAIDs)
Time Frame: 10 days
10 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Duration of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired)
Time Frame: 10 days
10 days
Severity of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) recorded in a "Symptom Diary".
Time Frame: 10 days
On a scale from 1 to 8.
10 days
Duration of fever, defined as the total number of hours that the child has a core temperature >38oC measured twice per day.
Time Frame: 10 days
10 days
Amount of NSAIDs used.
Time Frame: 10 days
10 days
Number of children receiving antibiotic treatment in each treatment group.
Time Frame: 10 days
10 days
Total amount of days of antibiotic use during the study, reported during the whole duration of the study in a the "Symptom Diary".
Time Frame: 10 days
10 days
Number of unplanned medical visits (other than "Visit 1 and 2").
Time Frame: 10 days
This outcome is defined as the total amount of medical office visits or emergency visits.
10 days
Days of absences from day care center/school.
Time Frame: 10 days
This outcome is defined as the total amount of days of absences from the day care centre during the study, due to the presence of episodes of URTI.
10 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Milosevits Gergely

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 21, 2023

Primary Completion (Estimated)

November 30, 2025

Study Completion (Estimated)

November 30, 2025

Study Registration Dates

First Submitted

January 2, 2024

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 16, 2024

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SzentMiklósSzolgálatKft.

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Virus Diseases in Children

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

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bangladesh

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe