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

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: Recruiting
• Conditions: Upper Respiratory Tract Infections; Upper Resp Tract Infection
• Intervention / Treatment: Dietary supplement: Probiotic; Dietary supplement: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ADM Medical Team; Phone Number: +44 1460 243 230; Email: medical@protexin.com
• Study Contact Backup: Name: Atlantia Clinical Trials; Phone Number: +353 21 430 7442; Email: nring@atlantiatrials.com

Study Locations

• Ireland
  • Cork, Ireland, T23 R50R
    • Recruiting
    • Atlantia Food Clinical Trials
    • Contact: Niamh Ring; Phone Number: +353 21 430 7442; Email: nring@atlantiatrials.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

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)	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

Outcome Measure	Measure Description	Time Frame
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	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	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	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	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	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	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	Day 0, Day 90, Day 180

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Faecal Microbiome analysis	Shallow shotgun metagenomic sequencing for 20% of cohort	Day 0, Day 180

Collaborators and Investigators

• Sponsor: The Archer-Daniels-Midland Company
• Collaborators: Atlantia Food Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2023
• Primary Completion (Estimated): May 30, 2024
• Study Completion (Estimated): May 30, 2024

Study Registration Dates

• First Submitted: September 29, 2022
• First Submitted That Met QC Criteria: October 10, 2022
• First Posted (Actual): October 13, 2022

Study Record Updates

• Last Update Posted (Actual): April 30, 2024
• Last Update Submitted That Met QC Criteria: April 29, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: probiotic; microbiome
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID 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