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

Primary Purpose

Acute Upper Respiratory Tract Infection

Status
Completed
Phase
Not Applicable
Locations
Slovenia
Study Type
Interventional
Intervention
OMNi-BiOTiC® Active
Placebo
Sponsored by
University Maribor
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Acute Upper Respiratory Tract Infection

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts 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.

Sites / Locations

  • University of Maribor, Faculty of Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Multistrain Probiotic OMNi-BiOTiC® Active

Placebo

Arm 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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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
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

Full Information

First Posted
April 27, 2023
Last Updated
June 1, 2023
Sponsor
University Maribor
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1. Study Identification

Unique Protocol Identification Number
NCT05879393
Brief Title
The Multistrain Probiotic OMNi-BiOTiC® Active for Upper Respiratory Tract Infections in Older People
Acronym
ProURTI
Official Title
The Effect of the Multistrain Probiotic OMNi-BiOTiC® Active for Upper Respiratory Tract Infections in Older People: A Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
October 7, 2020 (Actual)
Primary Completion Date
February 13, 2022 (Actual)
Study Completion Date
July 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Maribor

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Upper Respiratory Tract Infection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Multistrain Probiotic OMNi-BiOTiC® Active
Arm Type
Experimental
Arm 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
rice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate
Intervention Type
Dietary Supplement
Intervention Name(s)
OMNi-BiOTiC® Active
Intervention Description
Multistrain probiotic
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
rice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate
Primary Outcome Measure Information:
Title
Incidence of URTI
Description
Comparison of the incidence of acute upper respiratory tract infections among older people in both arms
Time Frame
12 weeks supplementation
Secondary Outcome Measure Information:
Title
Duration of URTI
Description
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
Title
Changes in concentration of leukocytes, neutrophils segm., lymphocytes, monocytes, eosinophils, basophils in serum
Description
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
Title
Changes in concentration of Immunoglobulin A (IgA) in serum
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabina Fijan, Ph.D
Organizational Affiliation
University of Maribor, Faculty of Health Sciences
Official's Role
Study Director
Facility Information:
Facility Name
University of Maribor, Faculty of Health Sciences
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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