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The goal of this randomised controlled trial is to determine the effect of consuming a multistrain probiotic OMNi-BiOTiC® Active to shorten the incidence and duration of acute upper respiratory tract infections (URTIs) in older people. The main questions it aims to answer is:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multistrain Probiotic OMNi-BiOTiC® Active | Experimental | Lacticaseibacillus casei W56, Lactobacillus acidophilus W37, Ligilactobacillus salivarius W24, Levilactobacillus brevis W63, Lactococcus lactis W58, Lactococcus lactis W19, Bifidobacterium animalis subsp. lactis W52, Bifidobacterium longum subsp. longum W108, Bifidobacterium breve W25, Bifidobacterium animalis subsp. lactis W51 and Bifidobacterium bifidum W23. Additional ingredients:corn starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate and vanillin |
|
| Placebo | Placebo Comparator | rice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OMNi-BiOTiC® Active | Dietary Supplement | Multistrain probiotic |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of URTI | Comparison of the incidence of acute upper respiratory tract infections among older people in both arms | 12 weeks supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of URTI | Comparison of the duration of acute upper respiratory tract infections among older people in both arms via the use of a questionnaire | 12 weeks supplementation |
| Changes in concentration of leukocytes, neutrophils segm., lymphocytes, monocytes, eosinophils, basophils in serum |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sabina Fijan, Ph.D | University of Maribor, Faculty of Health Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Maribor, Faculty of Health Sciences | Maribor | 2000 | Slovenia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37512932 | Derived | Strauss M, Micetic Turk D, Lorber M, Pogacar MS, Kozelj A, Tusek Bunc K, Fijan S. The Multi-Strain Probiotic OMNi-BiOTiC(R) Active Reduces the Duration of Acute Upper Respiratory Disease in Older People: A Double-Blind, Randomised, Controlled Clinical Trial. Microorganisms. 2023 Jul 5;11(7):1760. doi: 10.3390/microorganisms11071760. |
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| Placebo |
| Other |
rice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate |
|
Differences in the serum concentration of leukocytes, neutrophils segm., lymphocytes, monocytes, eosinophils, basophils, measured in 10x9/L of the participants in the first winter season as a change from baseline to 12 weeks upon administration of probiotics compared to placebo |
| 12 weeks supplementation |
| Changes in concentration of Immunoglobulin A (IgA) in serum | Differences in the serum concentration of immunoglobulin A (IgA), measured in g/L of the participants in the first winter season as a change from baseline to 12 weeks upon administration of probiotics compared to placebo | 12 weeks supplementation |