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

The Archer-Daniels-Midland Company

Status: Completed

Conditions: Upper Resp Tract Infection; Upper Respiratory Tract Infections

Treatments: Dietary Supplement: Probiotic; Dietary Supplement: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT05577065

CTB2022TN108

AFCRO158 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 200 patients

Sex: All

Ages: 2 to 8 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

200 participants in 2 patient groups, including a placebo group

Active

Experimental group

Description:

Arm receiving investigational product (probiotic)

Treatment:

Dietary Supplement: Probiotic

Placebo

Placebo Comparator group

Description:

Arm receiving placebo

Treatment:

Dietary Supplement: Placebo