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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

142 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-21

Study Completion Date

2025-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Virus Diseases in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DIETARY_SUPPLEMENT

BioGaia Pharax drops (with PTA5289 and DSM 17938) with vitamin D3 will be manufactured and delivered by BioGaia AB as oil suspension.

Placebo

Placebo taken orally once in the morning and once in the evening, each time 5 drops.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo product contains vitamin D3 and is identical to the active product but lacks L. reuteri.

Interventions

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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.

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo product contains vitamin D3 and is identical to the active product but lacks L. reuteri.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No