An interventional study of OMNi-BiOTiC® Active and Placebo in Acute Upper Respiratory Tract Infection, sponsored by University Maribor. Completed at 1 site in Slovenia. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-06-05.
Sponsored by University Maribor · Not applicable, Interventional, and Prevention
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:
Exclusion Criteria:
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
Dietary Supplement: OMNi-BiOTiC® Active
rice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate
Other: Placebo
Multistrain probiotic
rice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate
Incidence of URTI
Comparison of the incidence of acute upper respiratory tract infections among older people in both arms
Time frame: 12 weeks supplementation
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
Time frame: 12 weeks supplementation
Changes in concentration of leukocytes, neutrophils segm., lymphocytes, monocytes, eosinophils, basophils in serum
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
Time frame: 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
Time frame: 12 weeks supplementation
Plan to share: No
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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.
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University Maribor