Upper respiratory tract infections with pharyngitis, of likely viral origin, in children 6 months to 5 years old Respiratory
Conditions
Interventions
Using a centralised computer-based randomisation list, patients are randomised 1:1 to receive either probiotic capsules or indentical-looking placebo capsules, to be taken orally twice daily for 15 da
Sponsors
AB-BIOTICS SA (KANEKA Corp.)
Eligibility
Sex/Gender
All
Age
6 Months to 5 Years
Inclusion criteria
Inclusion criteria: 1. Infants and children, 6 months to 5 years old, with upper respiratory infection of likely viral origin (based on investigator's judgment of symptoms) with pharyngitis. 2. Having a FLACC score ("Face, Legs, Activity, Cry and Consolability"; Merkel et al. Pediatric Nursing 1997, 23:293-297) > 3 and body temperature >37.5ºC. 3. Symptoms started within 48h of entry visit. 4. Written informed consent provided by parents or caregivers.
Exclusion criteria
Exclusion criteria: 1. Tonsillitis, cervical lymphadenitis, otitis media or scarlatiniform rash (symptoms suggestive of bacterial infection). 2. Preterm infants or those having been born weighting <2500gr. 3. Failure to thrive 4. Use of antibiotics, antivirals or probiotics for more than 48h within 2 weeks of study entry. 5. Breastfed children whose mothers have taken antibiotics, antivirals or probiotics for more than 48h within 2 weeks of study entry. 6. History of two or more invasive infections (meningitis, osteomielitis, sepsis). 7. History of recurrent, severe respiratory infections within 12 months of study entry 8. Chronic diarrhea or gastroesophagic reflux disease (GERD). 9. Congenital heart, respiratory or digestive disease. 10. Primary or secondary immunodeficiency. 11. Asthma. 12. Any other condition that, according to the judgment of the principal investigator, warrants exclusion from the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Numer of days with fever (body temperature >37.5ºC), as measured with a thermometer, and number of days with pain score >3, as measured with the FLACC score ("Face, Legs, Activity, Cry and Consolability"; Merkel et al. Pediatric Nursing 1997, 23:293-297), both recorded daily by parents in a diary from day 1 to 15 of intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Area under the curve (AUC) of the FLACC score ("Face, Legs, Activity, Cry and Consolability"; Merkel et al. Pediatric Nursing 1997, 23:293-297), as recorded daily by parents in a diary from day 1 to 15 of intervention. 2. Area under the curve (AUC) of body temperature (in Celsius degrees), as recorded daily by parents in a diary from day 1 to 15 of intervention. 3. Etiological agent (using multiplex PCR for 16 respiratory viruses), as determined on nasopharyngeal swabs taken on day 0. 4. Metabolome analysis (polar and semi-polar metabolites, as analysed by HPLC-MS) of salivary samples taken on days 1 and 15. 5. Concentration of immunoglobulin A (IgA), TNF-alpha and interleukins 1b, 4, 6, 10, 17 and 18 in salivary samples taken on days 1 and 15. 6. Number of days with cough, as recorded daily by parents in a diary from day 1 to 15 of intervention. 7. Number of days with nasal congestion, as recorded daily by parents in a diary from day 1 to 15 of intervention. 8. Number of days with rhinorrhea, as recorded daily by parents in a diary from day 1 to 15 of intervention. 9. Number of days of intake of NSAIDs (ibuprofen), as recorded daily by parents in a diary from day 1 to 15 of intervention. 10. Number of days of intake of antihistaminics (cetirizine), as recorded daily by parents in a diary from day 1 to 15 of intervention. 11. Number of days of intake of antibiotics rescue medication, as recorded daily by parents in a diary from day 1 to 15 of intervention. 12. Number of medical or emergency visits, as recorded daily by parents in a diary from day 1 to 15 of intervention. 13. Number of medical or emergency visits after day 15, as recorded during face-to-face visits on days 30 and 60. 14. Number of different symptoms (of FLACC>3, fever >37.5ºC, presence of cough, rhinorrhea and nasal congestion), as recorded daily by parents in a diary from day 1 to 15 of intervention. 15. Number of different symptoms (of FLACC>3, fever >37.5ºC, presence of cough, rhinorrhea and na | — |
Countries
Mexico
Contacts
Public ContactJordi Espadaler-Mazo
Outcome results
None listed