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

Not Applicable

Recruiting

• Conditions: Virus Diseases in Children
• Interventions: Other: Placebo; Dietary Supplement: BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)

• Registration Number: NCT06205966
• Lead Sponsor: Milosevits Gergely

Brief 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.

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 Timeline

• Study Start: 2023-12-21
• Status Verified: 2024-01
• Study First Submitted: 2024-01-02
• Study First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Study First Posted: 2024-01-16
• Last Update Posted: 2024-01-16
• Primary Completion: 2025-11-30
• Study Completion: 2025-11-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 142

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Placebo taken orally once in the morning and once in the evening, each time 5 drops.
Probiotics	BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938)	Study product containing L. reuteri (PTA5289 and DSM 17938) taken orally once in the morning and once in the evening, each time 5 drops.

Primary Outcome Measures

Name	Time	Method
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)	10 days

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Szent Miklós Szolgálat Kft.; 🇭🇺 Szigetszentmiklós, Pest, Hungary