Infections, Upper Respiratory Tract
Conditions
Brief summary
This study is a randomized, double-blind, placebo-controlled, two-armed, parallel-group study in healthy children aged 2-6 years. The study will investigate the effect of daily intake of a probiotic on Upper Respiratory Tract Infections (URTI) during a 16-week intervention.
Interventions
DIETARY_SUPPLEMENTProbiotic strain
Lactobacillus
DIETARY_SUPPLEMENTPlacebo
Placebo
Sponsors
Onorach Clinical
CPS Research
Chr Hansen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes
Inclusion criteria
1. Children aged 2-6 years, both inclusive, at the time of informed consent 2. No URTI at the time of inclusion as assessed by a GP 3. Attending day-care with at least 10 children or primary school with at least 10 children in the class for at least 20 hours a week 4. Generally healthy as determined by a GP 5. Guardian consents to participate in the study and to comply with all its procedures
Exclusion criteria
1. Any known concomitant chronic infections, chronic systemic diseases, autoimmune diseases (e.g. asthma), immunodeficiency, metabolic diseases, chronic respiratory tract diseases including respiratory allergies and cystic fibrosis, congenital cardiac defects. 2. Suspected or challenge-proved food allergy 3. Use of any prescribed immune suppressive medications at enrolment 4. Use of oral or IV antibiotics in the 1 month before randomisation 5. Not willing to exclude pre/pro/synbiotics during the study 6. Intake of Echinacea, high dose vitamins or Zinc four weeks before and during the study period. 7. Language limitations regarding interviews or questionnaires 8. Participation in other clinical studies in the last 2 months 9. Planning extensive travel (for \>1 month) during the duration of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of URTI | 16 weeks | The incidence of URTI measured as the number of URTI episodes diagnosed by a GP according to the prespecified, well-defined criteria, adjusted for sample size. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Number of days with URTI symptoms | 16 weeks | The number of days with URTI symptoms for URTIs that were diagnosed by a GP, adjusted for sample size. |
| The number of days with temperature ≥ 38 °C | 16 weeks | The number of days with temperature ≥ 38 °C during an URTI episode, which was diagnosed by a GP, adjusted for sample size. |
| The incidence of URTI with pathogens | 16 weeks | The incidence of URTI measured as the number of URTI episodes diagnosed by a GP according to the prespecified, well-defined criteria, for which a pathogen is identified in nasal swabs, adjusted for sample size. |
| The number of subjects with one or more episode of URTI | 16 weeks | The number of subjects with one or more episode of URTI, which was diagnosed by a GP, adjusted for sample size. |
| The number of days of absence from daycare or primary school | 16 weeks | The number of days of absence from daycare or primary school during an URTI, which was diagnosed by a GP, adjusted for sample size. |
| WURSS-K score | 16 weeks | The Area under Curve for daily Wisconsin Upper Respiratory Symptom Survey for Kids (WURSS-K) score (range: not sick - very sick) during an URTI episode, which was diagnosed by a GP, adjusted for sample size. |
Countries
United Kingdom
Outcome results
None listed