Virus Diseases in Children
Conditions
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.
Interventions
DIETARY_SUPPLEMENTBioGaia 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.
OTHERPlacebo
Placebo product contains vitamin D3 and is identical to the active product but lacks L. reuteri.
Sponsors
Milosevits Gergely
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
4 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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) | 10 days |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| Duration of fever, defined as the total number of hours that the child has a core temperature >38oC measured twice per day. | 10 days | — |
| Amount of NSAIDs used. | 10 days | — |
| Duration of symptoms (runny nose, stuffy nose, sneezing, sore throat, cough, feeling tired) | 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. |
| 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. |
| Number of children receiving antibiotic treatment in each treatment group. | 10 days | — |
Countries
Hungary
Contacts
Primary ContactGergely Milosevits, MD, PhD
Outcome results
None listed