Upper Respiratory Tract InfectionsKLEENEXNCT05577065
A Study to Assess the Effect of a Probiotic on Upper Respiratory Tract Infections in Healthy Children
A study testing Probiotic in people with Upper Respiratory Tract Infections and Upper Resp Tract Infection, run by The Archer-Daniels-Midland Company at 1 site in Ireland.
Trial summary
This study evaluates the efficacy of a single strain probiotic on the incidence, duration and severity of upper respiratory tract infections in healthy, school-age children. Read more about this study
- Who is it for?
- Ages 2 to 8 yearsHealthy volunteers can take part
- Conditions the study is for
- Upper Respiratory Tract Infections, Upper Resp Tract Infection
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteIreland
- Study dates
- 30 Jan 2023to 13 Mar 2024
- 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 2 to 8 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Have a parent/guardian able to give written informed consent.
- If ≥7 years, be able to give written informed assent.
- Healthy children aged 2 - 8 years old.
- In general good health, as determined by the investigator.
- Attending a registered childcare provider or school.
- Willing to consume the study product daily for the duration of the study.
Who cannot join
- Has URTI symptoms at the time of randomisation.
- Are <2 or ≥9 years old.
- Diagnosed with concomitant chronic infections, chronic systemic diseases, autoimmune diseases (e.g. asthma - generally only formally diagnosed after child is 6 years), immunodeficiency, metabolic diseases, chronic respiratory tract diseases including respiratory allergies and cystic fibrosis or congenital cardiac defects.
- Has a family household member that smokes cigarettes in the home.
- Has taken antibiotics within the previous 2 weeks prior to randomisation.
- Has taken probiotic supplements within the previous 2 weeks prior to randomisation
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- Daily intake of immune stimulating products, including but not limited to echinacea, vitamin C and zinc in the 2 weeks before randomisation (multivitamins allowed).
- Has any significant health conditions that would prevent them from fulfilling the study requirements, put the Participant at risk or would confound the interpretation of the study results as judged by the investigator on the basis of medical history and routine laboratory test results.
- Taking a medication that the investigator believes would interfere with the objectives of the study or pose a safety risk or confound the interpretation of the study results.
- Has an active gastrointestinal disorder or previous gastrointestinal surgery (appendicectomy allowed).
- Has a gastrointestinal or chronic infective disease (i.e., coeliac disease, diarrhoea, Crohn's disease, ulcerative colitis, irritable bowel syndrome, diverticulosis, stomach or duodenal ulcers, hepatitis, HIV, cancer, etc.), or with a history of such diseases.
- Planned extensive travel (for >1 month) during the study duration.
- Parent/guardian who, in the opinion of the investigator, are considered to be poor attendees or unlikely for any reason to be able to comply with the study.
- Participants may not be receiving treatment involving experimental drugs. If the Participant has been in a recent experimental trial/study, these must have been completed not less than 60 days prior to this study.
- Any Participant who is the child of an employee of the study site or an Atlantia Clinical Trials employee or their close family member or a member of their household.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised, Double-blinded, Placebo-controlled, Parallel Study, to Assess the Effect of a Probiotic on the Incidence, Duration and Severity of Upper Respiratory Tract Infections in Healthy Children
This study evaluates the efficacy of a single strain probiotic on the incidence, duration and severity of upper respiratory tract infections in healthy, school-age children.
- Being tested
- Probiotic, Placebo
- Keywords
- probiotic, microbiome
- Medical subject headings
- Respiratory Tract Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticDietary supplement
Single strain probiotic in the form of a sachet with a daily dose of 3E+9 Colony Forming Unit (CFU) per day for 26 weeks.
PlaceboDietary supplement
Matching placebo in the form of a sachet once daily for 26 weeks
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | Arm receiving investigational product (probiotic) Receives: Dietary Supplement: Probiotic |
| Placebo | Placebo comparator | Arm receiving placebo Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of 26 week consumption of probiotic on the total number of days that, otherwise healthy, children suffer from upper respiratory tract infection (URTI)
Presence of an URTI defined by a score of >2 on the Jackson Cold Scale (maximum score 3) where a lower score means better outcomes compared to baseline
Measured: Entire follow up period (total of 180 days)
Secondary outcomes (7)
Effect of 26 week consumption of probiotic on the number of children reporting at least one URTI
The presence of an URTI defined by a score of >2 on the Jackson Cold Scale (maximum score 3) where a lower score means better outcomes compared to baseline
Measured: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on the average duration of URTIs reported by participants
Duration of URTI measured through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
Measured: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on the severity of URTI-related symptoms reported by participants
Severity of URTI measured through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
Measured: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on the total number of reported missed days of school/childcare due to illness
Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
Measured: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on the reported incidence of antibiotic use
Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
Measured: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on Salivary Immunoglobulin A levels (IgA) (mg/dL)
Measured via saliva sample
Measured: Day 0, Day 180
Effect of 26 week consumption of probiotic on the incidence of gastrointestinal infections
Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
Measured: Day 0, Day 90, Day 180
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2022
- Study start30 Jan 2023
- Primary completion13 Mar 2024
- Study completion13 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Upper Respiratory Tract InfectionsStudies 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
- Model description
- study consists of 2 arms, intervention and placebo.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Archer-Daniels-Midland Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05577065
- Sponsor's protocol ID
- CTB2022TN108
- Other IDs
- AFCRO158
- Acronym
- KLEENEX
- Status last verified
- Nov 2024
- First submitted
- 29 Sep 2022
- Last updated
- 9 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised, Double-blinded, Placebo-controlled, Parallel Study, to Assess the Effect of a Probiotic on the Incidence, Duration and Severity of Upper Respiratory Tract Infections in Healthy Children
- ClinicalTrials.gov ID
- NCT05577065
- Acronym / sponsor ID
- KLEENEX / CTB2022TN108
- Keywords
- probiotic, microbiome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- The Archer-Daniels-Midland CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Atlantia Food Clinical Trials
- Study start
- 30 Jan 2023 (actual)
- Primary completion
- 13 Mar 2024 (actual)
- Study completion
- 13 Mar 2024 (actual)
- First posted
- 13 Oct 2022 (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.
This study evaluates the efficacy of a single strain probiotic on the incidence, duration and severity of upper respiratory tract infections in healthy, school-age children.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- study consists of 2 arms, intervention and placebo.
| Arm | Type | Receives |
|---|---|---|
| Active | Experimental | Dietary Supplement: ProbioticArm receiving investigational product (probiotic) |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboArm receiving placebo |
Who may qualify
- Ages
- 2 to 8 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Have a parent/guardian able to give written informed consent.
- If ≥7 years, be able to give written informed assent.
- Healthy children aged 2 - 8 years old.
- In general good health, as determined by the investigator.
- Attending a registered childcare provider or school.
Key exclusion criteria (15 listed)
- Has URTI symptoms at the time of randomisation.
- Are <2 or ≥9 years old.
- Diagnosed with concomitant chronic infections, chronic systemic diseases, autoimmune diseases (e.g. asthma - generally only formally diagnosed after child is 6 years), immunodeficiency, metabolic diseases, chronic respiratory tract diseases including respiratory allergies and cystic fibrosis or congenital cardiac defects.
- Has a family household member that smokes cigarettes in the home.
- Has taken antibiotics within the previous 2 weeks prior to randomisation.
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 |
|---|---|---|
| ProbioticSingle strain probiotic in the form of a sachet with a daily dose of 3E+9 Colony Forming Unit (CFU) per day for 26 weeks. | Dietary supplement | Active |
| PlaceboMatching placebo in the form of a sachet once daily for 26 weeks | Dietary supplement | Placebo |
Primary outcome
Effect of 26 week consumption of probiotic on the total number of days that, otherwise healthy, children suffer from upper respiratory tract infection (URTI)
Time frame: Entire follow up period (total of 180 days)
Presence of an URTI defined by a score of >2 on the Jackson Cold Scale (maximum score 3) where a lower score means better outcomes compared to baseline
7 secondary outcomes
Effect of 26 week consumption of probiotic on the number of children reporting at least one URTI
Time frame: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on the average duration of URTIs reported by participants
Time frame: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on the severity of URTI-related symptoms reported by participants
Time frame: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on the total number of reported missed days of school/childcare due to illness
Time frame: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on the reported incidence of antibiotic use
Time frame: Day 0, Day 90, Day 180
Effect of 26 week consumption of probiotic on Salivary Immunoglobulin A levels (IgA) (mg/dL)
Time frame: Day 0, Day 180
Effect of 26 week consumption of probiotic on the incidence of gastrointestinal infections
Time frame: Day 0, Day 90, Day 180
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 9 Apr 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Upper Respiratory Tract Infections and Upper Resp Tract Infection, run by The Archer-Daniels-Midland Company at 1 site in Ireland.
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 6 inclusion and 15 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 9 Apr 2025. 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 Ireland. 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?
Effect of 26 week consumption of probiotic on the total number of days that, otherwise healthy, children suffer from upper respiratory tract infection (URTI) (time frame: Entire follow up period (total of 180 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Apr 2025; AzTrials last refreshed its copy on 6 Nov 2026.