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The purpose of this study is to assess the potential of probiotics in prevention of respiratory tract infections and their complications in children
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 1 g of rice maltodextrin will be reconstituted in 25-50 ml of tepid water or juice and immediately fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer. |
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| Probiotic | Experimental | powder of L. acidophilus DDS-1, B. lactis UABLA-12, 50 mg of fructooligosaccharide 1 g of probiotic will be reconstituted in 25-50 ml tepid water or juice and immediately fed once a day (5 billion CFU/daily) for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L. acidophilus DDS-1, B. lactis UABLA-12 | Dietary Supplement | 1 g of probiotic will be reconstituted in 25-50 ml tepid water, juice or age specific baby food and immediately fed once a day (5 billion CFU/daily) for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer. |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of respiratory tract infection episodes in a child | An episode will be defined as display of fever, cough, rhinitis, and sore throat or combination thereof for longer than 48 hours | 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of respiratory tract infection | Time to CARIFS (Canadian Acute Respiratory Illness and Flu Scale) value 0 | 21 days |
| Severity of respiratory tract infection | a product of daily CARIFS times the duration of the disease |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sergei V Gerasimov, M.D., Ph.D. | Lviv National Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lviv City Children Hospital | Lviv | Lviv Oblast | 79059 | Ukraine |
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| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D012140 | Respiratory Tract Diseases |
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| Placebo | Dietary Supplement | 1 g in 25-50 ml of tepid water or juice fed once a day for 2-weeks trial period or to the end of acute respiratory infection depending on whatever is longer. |
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| 21 days |
| Complications of respiratory tract infections | Percent of otitis, sinusitis, bronchitis, pneumonia cases | 21 days |
| Antibiotic prescriptions | Percent | 21 days |
| Hospitalization rate | Number of hospitalizations | 21 days |
| Number of unscheduled doctor visits | 21 days |
| Number of days daycare/school missed | 21 days |
| Number of workdays missed by parents | 21 days |
| Time to resolution of individual CARIFS item | Days to the correspondent CARIFS item 0 | 21 |
| 25% and 50% decrease in the CARIFS score | 25% and 50% decrease in the CARIFS score | 21day |
| Percent and duration of the use of over-the-counter medications | Percent and duration of the use of over-the-counter medications | 21day |