Clinical trial NCT05577065: A Study to Assess the Effect of a Probiotic on Upper Respiratory Tract Infections in Healthy Children
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Upper Respiratory Tract Infections
Upper Resp Tract Infection
Keywords: probiotic
microbiome
Lead sponsor: The Archer-Daniels-Midland Company
Sponsor class: INDUSTRY
Collaborators: name: Atlantia Food Clinical Trials
First posted: 2022-10-13
Enrollment: 200
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: study consists of 2 arms, intervention and placebo.
Primary purpose: PREVENTION

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.


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.

Primary outcomes:
measure: Effect of 26 week consumption of probiotic on the total number of days that, otherwise healthy, children suffer from upper respiratory tract infection (URTI)
timeFrame: Entire follow up period (total of 180 days)
Secondary outcomes:
measure: Effect of 26 week consumption of probiotic on the number of children reporting at least one URTI
timeFrame: Day 0, Day 90, Day 180
measure: Effect of 26 week consumption of probiotic on the average duration of URTIs reported by participants
timeFrame: Day 0, Day 90, Day 180
measure: Effect of 26 week consumption of probiotic on the severity of URTI-related symptoms reported by participants
timeFrame: Day 0, Day 90, Day 180
measure: Effect of 26 week consumption of probiotic on the total number of reported missed days of school/childcare due to illness
timeFrame: Day 0, Day 90, Day 180
measure: Effect of 26 week consumption of probiotic on the reported incidence of antibiotic use
timeFrame: Day 0, Day 90, Day 180
measure: Effect of 26 week consumption of probiotic on Salivary Immunoglobulin A levels (IgA) (mg/dL)
timeFrame: Day 0, Day 180
measure: Effect of 26 week consumption of probiotic on the incidence of gastrointestinal infections
timeFrame: Day 0, Day 90, Day 180
Other outcomes:
measure: Faecal Microbiome analysis
timeFrame: Day 0, Day 180
Locations:
city: Cork
country: Ireland
facility: Atlantia Food Clinical Trials
Study officials:
References: