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

NCT05577065 | Completed

• 2 other identifiers: CTB2022TN108AFCRO158
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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

Keywords

probiotic; microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Effect of 26 week consumption of probiotic on the number of children reporting at least one URTI

  Day 0, Day 90, Day 180

• Effect of 26 week consumption of probiotic on the average duration of URTIs reported by participants

  Day 0, Day 90, Day 180

• Effect of 26 week consumption of probiotic on the severity of URTI-related symptoms reported by participants

  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

  Day 0, Day 90, Day 180

• Effect of 26 week consumption of probiotic on the reported incidence of antibiotic use

  Day 0, Day 90, Day 180

Other Outcomes (1)

• Faecal Microbiome analysis

  Day 0, Day 180

Study Arms (2)

Active

EXPERIMENTAL

Arm receiving investigational product (probiotic)

Dietary Supplement: Probiotic

Placebo

PLACEBO COMPARATOR

Arm receiving placebo

Dietary Supplement: Placebo

Interventions

Probiotic 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.

Active

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• The Archer-Daniels-Midland Company: lead
• Atlantia Food Clinical Trials: collaborator

Study Sites (1)

Atlantia Food Clinical Trials

Cork, T23 R50R, Ireland

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: study consists of 2 arms, intervention and placebo.

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 13, 2022
• Study Start: January 30, 2023
• Primary Completion: March 13, 2024
• Study Completion: March 13, 2024
• Last Updated: April 9, 2025

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IE (1)