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

The Effect of the Multistrain Probiotic OMNi-BiOTiC® Active for Upper Respiratory Tract Infections in Older People: A Randomised Controlled Trial

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 Overview

• Status: Completed
• Conditions: Acute Upper Respiratory Tract Infection
• Intervention / Treatment: Other: Placebo; Dietary supplement: OMNi-BiOTiC® Active

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Slovenia
  • Maribor, Slovenia, 2000
    • University of Maribor, Faculty of Health Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; rice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate	Other: Placebo; rice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate
Experimental: Multistrain Probiotic OMNi-BiOTiC® Active; 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; Multistrain probiotic

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: University Maribor
• Investigators: Study Director: Sabina Fijan, Ph.D, University of Maribor, Faculty of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 7, 2020
• Primary Completion (Actual): February 13, 2022
• Study Completion (Actual): July 13, 2022

Study Registration Dates

• First Submitted: April 27, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): May 30, 2023

Study Record Updates

• Last Update Posted (Actual): June 5, 2023
• Last Update Submitted That Met QC Criteria: June 1, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: UMaribor

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No