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

NCT ID: NCT05879393

Last Updated: 2023-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

95 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-07

Study Completion Date

2022-07-13

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Upper Respiratory Tract Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

OMNi-BiOTiC® Active

Intervention Type DIETARY_SUPPLEMENT

Multistrain probiotic

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

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OMNi-BiOTiC® Active

Multistrain probiotic

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Maribor

OTHER

Sponsor Role lead

Responsible Party

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Sabina Fijan

Assoc. prof. dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sabina Fijan, Ph.D

Role: STUDY_DIRECTOR

University of Maribor, Faculty of Health Sciences

Locations

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University of Maribor, Faculty of Health Sciences

Maribor, , Slovenia

Site Status

Countries

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Slovenia

References

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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.

Reference Type DERIVED
PMID: 37512932 (View on PubMed)

Other Identifiers

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UMaribor

Identifier Type: -

Identifier Source: org_study_id

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