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

Upper Respiratory Tract Infections Clinical Trial

— KLEENEX  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05577065
• Other study ID #: CTB2022TN108
• Secondary ID: AFCRO158
• Status: Recruiting
• Phase: N/A
• Start date: January 30, 2023
• Est. completion date: May 30, 2024

Study information

• Verified date: April 2024
• Source: The Archer-Daniels-Midland Company
• Contact: ADM Medical Team
• Phone: +44 1460 243 230
• Email: medical[@]protexin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: May 30, 2024
• Est. primary completion date: May 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 8 Years

Eligibility

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.

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Respiratory Tract Infections
• Upper Resp Tract Infection
• Upper Respiratory Tract Infections

Intervention

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.
• Placebo
Matching placebo in the form of a sachet once daily for 26 weeks

Locations

Country	Name	City	State
Ireland	Atlantia Food Clinical Trials	Cork

Sponsors (2)

Lead Sponsor	Collaborator
The Archer-Daniels-Midland Company	Atlantia Food Clinical Trials

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Faecal Microbiome analysis	Shallow shotgun metagenomic sequencing for 20% of cohort	Day 0, Day 180
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Effect of 26 week consumption of probiotic on Salivary Immunoglobulin A levels (IgA) (mg/dL)	Measured via saliva sample	Day 0, Day 180
Secondary	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