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| Name | Class |
|---|---|
| Vizera d.o.o. | INDUSTRY |
| University of Ljubljana | OTHER |
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Healthy preschool children will be recruited, gastrointestinal infection and respiratory infection symptoms will be followed during the 8-week treatment and 4-week follow-up period, to evaluate the effect of the used probiotic formula on immune system in comparison to the group using placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | Probiotic DE111® |
|
| Control group | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic Formula Bacillus subtilis DE111® | Dietary Supplement | Probiotic Formula Bacillus subtilis DE111®, 1 billion colony forming units (CFU) per day for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| The incidence of gastrointestinal and/or respiratory infections for experimental group compared to control group | Number of participants with at least one occurrence of gastrointestinal and/or respiratory infections during 12-week study period in the experimental group compared to control group. | 12-week study period (consisting of 8-week treatment plus 4-week follow-up) |
| The incidence of adverse events occuring in the experimental group compared to control group | Number of participants with treatment related adverse events during 12-week study period for both, experimental and control group. | 12-week study period (consisting of 8-week treatment plus 4-week follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lilijana Kocijancic Besednjak, MD, PhD | Health Center Nova Gorica | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health center Laško | Laško | 3270 | Slovenia | |||
| Pediatrija Krebs |
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| Placebo comparator | Dietary Supplement | Placebo comparator, once a day for 8 weeks |
|
| Maribor |
| 2000 |
| Slovenia |
| Pediatrinja d.o.o. | Maribor | 2000 | Slovenia |
| Zasebna otroska in solska ambulanta | Maribor | 2230 | Slovenia |
| Health Center Nova Gorica | Sempeter pri Gorici | 5290 | Slovenia |