Skip to main content
OpenTrials
Completed

NCT Number: NCT05879393

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Acute Upper Respiratory Tract Infection

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Maribor, Faculty of Health Sciences

Maribor, 2000, Slovenia

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

OMNi-BiOTiC® Active

Dietary Supplement

Multistrain probiotic

Placebo

Other

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

Primary outcomes

  1. Incidence of URTI

    Time frame: 12 weeks supplementation

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

Secondary outcomes

  1. Duration of URTI

    Time frame: 12 weeks supplementation

    Comparison of the duration of acute upper respiratory tract infections among older people in both arms via the use of a questionnaire

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

    Time frame: 12 weeks supplementation

    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

  3. Changes in concentration of Immunoglobulin A (IgA) in serum

    Time frame: 12 weeks supplementation

    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

Sponsors and collaborators

Lead sponsor

University Maribor

Other

Registry information

Official study title

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

Acronym: ProURTI

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 30, 2023
Registry last updated
Jun 5, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.