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

NCT ID: NCT05577065

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-30
• Study Completion Date: 2024-03-13

Brief 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.

Conditions

Upper Respiratory Tract Infections; Upper Resp Tract Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Active

Arm receiving investigational product (probiotic)

Group Type: EXPERIMENTAL

Probiotic

Intervention Type: DIETARY_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.

Placebo

Arm receiving placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Placebo

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 8 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Atlantia Food Clinical Trials

INDUSTRY

Sponsor Role: collaborator

The Archer-Daniels-Midland Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Atlantia Food Clinical Trials

Cork, , Ireland

Countries

Ireland

Other Identifiers

AFCRO158

Identifier Type: OTHER

Identifier Source: secondary_id

CTB2022TN108

Identifier Type: -

Identifier Source: org_study_id