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

NCT05879393 | Completed

• 1 other identifier: UMaribor
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Upper Respiratory Tract Infection

Outcome Measures

Primary Outcomes (1)

• Incidence of URTI

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

  12 weeks supplementation

Secondary Outcomes (3)

• Duration of URTI

  12 weeks supplementation

• Changes in concentration of leukocytes, neutrophils segm., lymphocytes, monocytes, eosinophils, basophils in serum

  12 weeks supplementation

• Changes in concentration of Immunoglobulin A (IgA) in serum

  12 weeks supplementation

Study Arms (2)

Multistrain Probiotic OMNi-BiOTiC® Active

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

OMNi-BiOTiC® Active DIETARY_SUPPLEMENT

Multistrain probiotic

Multistrain Probiotic OMNi-BiOTiC® Active

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Maribor: lead

Study Sites (1)

University of Maribor, Faculty of Health Sciences

Maribor, 2000, Slovenia

Location

Related Publications (1)

• Strauss M, Micetic Turk D, Lorber M, Pogacar MS, Kozelj A, Tusek Bunc K, Fijan S. The Multi-Strain Probiotic OMNi-BiOTiC(R) Active Reduces the Duration of Acute Upper Respiratory Disease in Older People: A Double-Blind, Randomised, Controlled Clinical Trial. Microorganisms. 2023 Jul 5;11(7):1760. doi: 10.3390/microorganisms11071760.

  PMID: 37512932 DERIVED

Study Officials

• Sabina Fijan, Ph.D

  University of Maribor, Faculty of Health Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. prof. dr.

Study Record Dates

• First Submitted: April 27, 2023
• First Posted: May 30, 2023
• Study Start: October 7, 2020
• Primary Completion: February 13, 2022
• Study Completion: July 13, 2022
• Last Updated: June 5, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

SL (1)