Acute Upper Respiratory Tract InfectionProURTINCT05879393
The Multistrain Probiotic OMNi-BiOTiC® Active for Upper Respiratory Tract Infections in Older People
A study testing OMNi-BiOTiC® Active in people with Acute Upper Respiratory Tract Infection, run by University Maribor at 1 site in Slovenia.
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. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Acute Upper Respiratory Tract Infection
- What is being tested?
- OMNi-BiOTiC® Active
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 95 participants
- Where
- 1 siteSlovenia
- Study dates
- 7 Oct 2020to 13 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Slovenia1 site
University of Maribor, Faculty of Health Sciences
Maribor, 2000
About this study
Official title: The Effect of the Multistrain Probiotic OMNi-BiOTiC® Active for Upper Respiratory Tract Infections in Older People: A Randomised Controlled Trial
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
- Being tested
- OMNi-BiOTiC® Active, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OMNi-BiOTiC® ActiveDietary supplement
Multistrain probiotic
PlaceboOther
rice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Dietary Supplement: OMNi-BiOTiC® Active |
| Placebo | Placebo comparator | rice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of URTI
Comparison of the incidence of acute upper respiratory tract infections among older people in both arms
Measured: 12 weeks supplementation
Secondary outcomes (3)
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
Measured: 12 weeks supplementation
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
Measured: 12 weeks supplementation
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
Measured: 12 weeks supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start7 Oct 2020
- Primary completion13 Feb 2022
- Study completion13 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Upper Respiratory Tract InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sabina Fijan, University Maribor
- Investigators
- Sabina Fijan, Ph.D, Study director, University of Maribor, Faculty of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879393
- Sponsor's protocol ID
- UMaribor
- Acronym
- ProURTI
- Status last verified
- Jun 2023
- First submitted
- 27 Apr 2023
- Last updated
- 5 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37512932
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Multistrain Probiotic OMNi-BiOTiC® Active for Upper Respiratory Tract Infections in Older People: A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT05879393
- Acronym / sponsor ID
- ProURTI / UMaribor
- Conditions
- Acute Upper Respiratory Tract Infection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- University MariborUniversity, hospital or other
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 13 Feb 2022 (actual)
- Study completion
- 13 Jul 2022 (actual)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Multistrain Probiotic OMNi-BiOTiC® Active | Experimental | Dietary Supplement: OMNi-BiOTiC® ActiveLacticaseibacillus 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 |
| Placebo | Placebo comparator | Other: Placeborice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OMNi-BiOTiC® ActiveMultistrain probiotic | Dietary supplement | Multistrain Probiotic OMNi-BiOTiC® Active |
| Placeborice starch, maltodextrin, plant protein, potassium chloride, magnesium sulphate, manganese sulphate | Other | Placebo |
Primary outcome
Incidence of URTI
Time frame: 12 weeks supplementation
Comparison of the incidence of acute upper respiratory tract infections among older people in both arms
3 secondary outcomes
Duration of URTI
Time frame: 12 weeks supplementation
Changes in concentration of leukocytes, neutrophils segm., lymphocytes, monocytes, eosinophils, basophils in serum
Time frame: 12 weeks supplementation
Changes in concentration of Immunoglobulin A (IgA) in serum
Time frame: 12 weeks supplementation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2023.
- Derived from this study: PubMed 37512932Strauss 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabina Fijan, Ph.D study director
University of Maribor, Faculty of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OMNi-BiOTiC® Active in people with Acute Upper Respiratory Tract Infection, run by University Maribor at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of URTI (time frame: 12 weeks supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05879393, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jun 2023.