Clinical trial NCT03636191: The Effect of a Probiotic on Upper Respiratory Tract Infections
Official 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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infections, Upper Respiratory Tract
Lead sponsor: Chr Hansen
Sponsor class: INDUSTRY
Collaborators: name: Onorach Clinical
name: CPS Research
First posted: 2018-08-17
Enrollment: 619
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: The incidence of URTI
timeFrame: 16 weeks
Secondary outcomes:
measure: The incidence of URTI with pathogens
timeFrame: 16 weeks
measure: The Number of days with URTI symptoms
timeFrame: 16 weeks
measure: The number of days with temperature ≥ 38 °C
timeFrame: 16 weeks
measure: WURSS-K score
timeFrame: 16 weeks
measure: The number of subjects with one or more episode of URTI
timeFrame: 16 weeks
measure: The number of days of absence from daycare or primary school
timeFrame: 16 weeks
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: CPS Research
Study officials:
affiliation: CPS Research
name: Gordon Crawford, DRCOG
role: PRINCIPAL_INVESTIGATOR
References:
citation: Damholt A, Keller MK, Baranowski K, Brown B, Wichmann A, Melsaether C, Eskesen D, Westphal V, Arltoft D, Habicht A, Gao Q, Crawford G. Lacticaseibacillus rhamnosus GG DSM 33156 effects on pathogen defence in the upper respiratory tract: a randomised, double-blind, placebo-controlled paediatric trial. Benef Microbes. 2022 Feb 28;13(1):13-23. doi: 10.3920/BM2021.0065. Epub 2021 Dec 13.