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

C

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

619 participants in 2 patient groups, including a placebo group

Probiotic
Experimental group
Treatment:
Dietary Supplement: Probiotic strain
Placebo
Placebo Comparator group
Treatment:
Dietary Supplement: Placebo

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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