The Effect of a Probiotic on Upper Respiratory Tract Infections

Not Applicable

Completed

• Conditions: Infections, Upper Respiratory Tract
• Interventions: Dietary Supplement: Probiotic strain; Dietary Supplement: Placebo

• Registration Number: NCT03636191
• Lead Sponsor: Chr Hansen

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-16
• Study First Posted: 2018-08-17
• Study Start: 2018-09-01
• Primary Completion: 2019-04-13
• Study Completion: 2019-08-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-09
• Last Update Posted: 2020-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 619

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Probiotic	Probiotic strain	-
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CPS Research; 🇬🇧 Glasgow, United Kingdom