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

University Maribor

Status: Completed

Conditions: Acute Upper Respiratory Tract Infection

Treatments: Dietary Supplement: OMNi-BiOTiC® Active; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT05879393

UMaribor

Details and patient eligibility

About

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.

Enrollment: 95 patients

Sex: All

Ages: 65+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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95 participants in 2 patient groups, including a placebo group

Multistrain Probiotic OMNi-BiOTiC® Active

Experimental group

Description:

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

Treatment:

Dietary Supplement: OMNi-BiOTiC® Active

Placebo

Placebo Comparator group

Description:

rice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate

Treatment:

Other: Placebo