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

Acute Upper Respiratory Tract Infection Clinical Trial

— ProURTI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05879393
• Other study ID #: UMaribor
• Status: Completed
• Phase: N/A
• Start date: October 7, 2020
• Est. completion date: July 13, 2022

Study information

• Verified date: June 2023
• Source: University Maribor
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: July 13, 2022
• Est. primary completion date: February 13, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Upper Respiratory Tract Infection
• Communicable Diseases
• Infections
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• OMNi-BiOTiC® Active
Multistrain probiotic

Other:
• Placebo
rice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate

Locations

Country	Name	City	State
Slovenia	University of Maribor, Faculty of Health Sciences	Maribor

Sponsors (1)

Lead Sponsor	Collaborator
University Maribor

Country where clinical trial is conducted

Slovenia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of URTI	Comparison of the incidence of acute upper respiratory tract infections among older people in both arms	12 weeks supplementation
Secondary	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
Secondary	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
Secondary	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