The Multistrain Probiotic OMNi-BiOTiC® Active for Upper Respiratory Tract Infections in Older People

University Maribor95 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

Conditions

Acute Upper Respiratory Tract Infection

Interventions

Eligibility

Sex: ALLMin age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Incidence of URTI

Comparison of the incidence of acute upper respiratory tract infections among older people in both arms

Time frame: 12 weeks supplementation

Secondary Outcomes

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

The Multistrain Probiotic OMNi-BiOTiC® Active for Upper Respiratory Tract Infections in Older People

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes