NCT03636191

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
619

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 17, 2018

Completed
15 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 13, 2019

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2019

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

7 months

First QC Date

August 16, 2018

Last Update Submit

July 9, 2020

Conditions

Infections, Upper Respiratory Tract

Outcome Measures

Primary Outcomes (1)

  • The incidence of URTI

    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.

    16 weeks

Secondary Outcomes (6)

  • The incidence of URTI with pathogens

    16 weeks

  • The Number of days with URTI symptoms

    16 weeks

  • The number of days with temperature ≥ 38 °C

    16 weeks

  • WURSS-K score

    16 weeks

  • The number of subjects with one or more episode of URTI

    16 weeks

  • +1 more secondary outcomes

Study Arms (2)

Probiotic

EXPERIMENTAL
Dietary Supplement: Probiotic strain

Placebo

PLACEBO COMPARATOR
Dietary Supplement: Placebo

Interventions

Probiotic strainDIETARY_SUPPLEMENT

Lactobacillus

Probiotic
PlaceboDIETARY_SUPPLEMENT

Placebo

Placebo

Eligibility Criteria

Age2 Years - 6 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Children aged 2-6 years, both inclusive, at the time of informed consent
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CPS Research

Glasgow, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 34895109DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract Diseases

Study Officials

  • Gordon Crawford, DRCOG

    CPS Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2018

First Posted

August 17, 2018

Study Start

September 1, 2018

Primary Completion

April 13, 2019

Study Completion

August 30, 2019

Last Updated

July 10, 2020

Record last verified: 2020-07

Locations

GB(1)