The Effect of a Probiotic on Upper Respiratory Tract Infections (PIP-U)

Chr. Hansen

Status

Completed

Conditions

Infections, Upper Respiratory Tract

Treatments

Dietary Supplement: Placebo

Dietary Supplement: Probiotic strain

Study type

Interventional

Funder types

Industry

Other

Identifiers

NCT03636191

HND-IM-030

Details and patient eligibility

About

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.

Enrollment

619 patients

Sex

All

Ages

2 to 6 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Children aged 2-6 years, both inclusive, at the time of informed consent
No URTI at the time of inclusion as assessed by a GP
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
Generally healthy as determined by a GP
Guardian consents to participate in the study and to comply with all its procedures

Exclusion criteria

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.
Suspected or challenge-proved food allergy
Use of any prescribed immune suppressive medications at enrolment
Use of oral or IV antibiotics in the 1 month before randomisation
Not willing to exclude pre/pro/synbiotics during the study
Intake of Echinacea, high dose vitamins or Zinc four weeks before and during the study period.
Language limitations regarding interviews or questionnaires
Participation in other clinical studies in the last 2 months
Planning extensive travel (for >1 month) during the duration of the study