A Study to Assess the Effect of a Probiotic on Upper Respiratory Tract Infections in Healthy Children (KLEENEX)

April 8, 2025 updated by: The Archer-Daniels-Midland Company

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Ireland
      • Cork, Ireland, T23 R50R
        • Atlantia Food Clinical Trials

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

2 years to 8 years (Child)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Have a parent/guardian able to give written informed consent.
  2. If ≥7 years, be able to give written informed assent.
  3. Healthy children aged 2 - 8 years old.
  4. In general good health, as determined by the investigator.
  5. Attending a registered childcare provider or school.
  6. Willing to consume the study product daily for the duration of the study.

Exclusion Criteria:

  1. Has URTI symptoms at the time of randomisation.
  2. Are <2 or ≥9 years old.
  3. 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.
  4. Has a family household member that smokes cigarettes in the home.
  5. Has taken antibiotics within the previous 2 weeks prior to randomisation.
  6. Has taken probiotic supplements within the previous 2 weeks prior to randomisation
  7. Daily intake of immune stimulating products, including but not limited to echinacea, vitamin C and zinc in the 2 weeks before randomisation (multivitamins allowed).
  8. 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.
  9. 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.
  10. Has an active gastrointestinal disorder or previous gastrointestinal surgery (appendicectomy allowed).
  11. 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.
  12. Planned extensive travel (for >1 month) during the study duration.
  13. 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.
  14. 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.
  15. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Arm receiving placebo
Dietary supplement: Placebo
Matching placebo in the form of a sachet once daily for 26 weeks
Experimental: Active
Arm receiving investigational product (probiotic)
Dietary supplement: Probiotic
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
Entire follow up period (total of 180 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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
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
Duration of URTI measured through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
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
Severity of URTI measured through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
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
Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
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
Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
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
Measured via saliva sample
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
Recorded through the WURSS-K questionnaire (Maximum score 42) where a lower score means better outcomes compared to baseline
Day 0, Day 90, Day 180

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Faecal Microbiome analysis
Time Frame: Day 0, Day 180
Shallow shotgun metagenomic sequencing for 20% of cohort
Day 0, Day 180

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Archer-Daniels-Midland Company

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Atlantia Food Clinical Trials

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 30, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 13, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 29, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 10, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 13, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 9, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CTB2022TN108
  • AFCRO158 (Other Identifier: Atlantia Food Clinical Trials)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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