Acute Upper Respiratory Tract Infection
Conditions
Brief summary
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: * Is the multistrain probiotic OMNi-BiOTiC® Active effective in reducing the incidence of URTIs in older people? * Is the multistrain probiotic OMNi-BiOTiC® Active effective in reducing the duration of URTIs in older people? * Is the multistrain probiotic OMNiBiOTiC® Active effective in changing selected immunological blood parameters in older people? Researchers will compare the probiotic group and the placebo group to see if the incidence or duration of URTIs are significant among the groups.
Interventions
DIETARY_SUPPLEMENTOMNi-BiOTiC® Active
Multistrain probiotic
OTHERPlacebo
rice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate
Sponsors
University Maribor
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 65 years or older at the signing of the written consent form * ability of participant to eat independently * ability of participant to adhere to all procedures of the clinical study
Exclusion criteria
* participants experienced an exacerbation of an existing chronic disease * participants experienced an exacerbation of metabolic diseases, * participants with mental incapacity to understand instructions * participants were prescribed long-term usage of antibiotics. * participants that changed their eating habits or consumed any probiotics 14 days * participants with markedly abnormal results of blood tests were excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of URTI | 12 weeks supplementation | Comparison of the incidence of acute upper respiratory tract infections among older people in both arms |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of URTI | 12 weeks supplementation | Comparison of the duration of acute upper respiratory tract infections among older people in both arms via the use of a questionnaire |
| Changes in concentration of leukocytes, neutrophils segm., lymphocytes, monocytes, eosinophils, basophils in serum | 12 weeks supplementation | 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 |
| Changes in concentration of Immunoglobulin A (IgA) in serum | 12 weeks supplementation | 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 |
Countries
Slovenia
Outcome results
None listed