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Completed

NCT Number: NCT03636191

The Effect of a Probiotic on Upper Respiratory Tract Infections

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.

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Key information

Conditions

Infections, Upper Respiratory Tract Infections Respiratory Tract Diseases Respiratory Tract Infections

Age range

2 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CPS Research

Glasgow, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Probiotic strain

Dietary Supplement

Lactobacillus

Placebo

Dietary Supplement

Placebo

Primary outcomes

  1. The incidence of URTI

    Time frame: 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 outcomes

  1. The incidence of URTI with pathogens

    Time frame: 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.

  2. The Number of days with URTI symptoms

    Time frame: 16 weeks

    The number of days with URTI symptoms for URTIs that were diagnosed by a GP, adjusted for sample size.

  3. The number of days with temperature ≥ 38 °C

    Time frame: 16 weeks

    The number of days with temperature ≥ 38 °C during an URTI episode, which was diagnosed by a GP, adjusted for sample size.

  4. WURSS-K score

    Time frame: 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.

  5. The number of subjects with one or more episode of URTI

    Time frame: 16 weeks

    The number of subjects with one or more episode of URTI, which was diagnosed by a GP, adjusted for sample size.

  6. The number of days of absence from daycare or primary school

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Chr Hansen

Industry

Collaborators

  • CPS Research
  • Onorach Clinical

Registry information

Official study title

The Effect of Lactobacillus Rhamnosus (LGG®) on the Defence Against Pathogens in the Upper Respiratory Tract in Healthy Children - a Single-center, Randomized, Double-blind, Placebo-controlled Study With 16 Weeks Intervention.

Acronym: PIP-U

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 17, 2018
Registry last updated
Jul 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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