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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotics | Active Comparator | Study product containing L. reuteri (PTA5289 and DSM 17938) taken orally once in the morning and once in the evening, each time 5 drops. |
|
| Placebo | Placebo Comparator | Placebo taken orally once in the morning and once in the evening, each time 5 drops. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BioGaia Pharax (L. reuteri PTA 5289 and DSM 17938) | Dietary Supplement | BioGaia Pharax drops (with PTA5289 and DSM 17938) with vitamin D3 will be manufactured and delivered by BioGaia AB as oil suspension. |
| Measure | Description | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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". | On a scale from 1 to 8. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gergely Milosevits, MD, PhD | Contact | +36308425722 | drgergelymilosevits@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Szent Miklós Szolgálat Kft. | Recruiting | Szigetszentmiklós | Pest County | 2310 | Hungary |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33789556 | Background | Maya-Barrios A, Lira-Hernandez K, Jimenez-Escobar I, Hernandez L, Ortiz-Hernandez A, Jimenez-Gutierrez C, Lopez-Velazquez G, Gutierrez-Castrellon P. Limosilactobacillus reuteri ATCC PTA 5289 and DSM 17938 as adjuvants to improve evolution of pharyngitis/tonsillitis in children: randomised controlled trial. Benef Microbes. 2021 Apr 12;12(2):137-145. doi: 10.3920/BM2020.0171. Epub 2021 Apr 1. |
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| Placebo | Other | Placebo product contains vitamin D3 and is identical to the active product but lacks L. reuteri. |
|
| 10 days |
| 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 |
| Number of children receiving antibiotic treatment in each treatment group. | 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"). | 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. | 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 |