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

Primary Purpose

Infections, Upper Respiratory Tract

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Probiotic strain
Placebo
Sponsored by
Chr Hansen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Infections, Upper Respiratory Tract

Eligibility Criteria

2 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CPS Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The incidence of URTI with pathogens
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.
The Number of days with URTI symptoms
The number of days with URTI symptoms for URTIs that were diagnosed by a GP, adjusted for sample size.
The number of days with temperature ≥ 38 °C
The number of days with temperature ≥ 38 °C during an URTI episode, which was diagnosed by a GP, adjusted for sample size.
WURSS-K score
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.
The number of subjects with one or more episode of URTI
The number of subjects with one or more episode of URTI, which was diagnosed by a GP, adjusted for sample size.
The number of days of absence from daycare or primary school
The number of days of absence from daycare or primary school during an URTI, which was diagnosed by a GP, adjusted for sample size.

Full Information

First Posted
August 16, 2018
Last Updated
July 9, 2020
Sponsor
Chr Hansen
Collaborators
Onorach Clinical, CPS Research
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1. Study Identification

Unique Protocol Identification Number
NCT03636191
Brief Title
The Effect of a Probiotic on Upper Respiratory Tract Infections
Acronym
PIP-U
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

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 1, 2018 (Actual)
Primary Completion Date
April 13, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chr Hansen
Collaborators
Onorach Clinical, CPS Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Upper Respiratory Tract

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
619 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Probiotic
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic strain
Intervention Description
Lactobacillus
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
The incidence of URTI
Description
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.
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
The incidence of URTI with pathogens
Description
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.
Time Frame
16 weeks
Title
The Number of days with URTI symptoms
Description
The number of days with URTI symptoms for URTIs that were diagnosed by a GP, adjusted for sample size.
Time Frame
16 weeks
Title
The number of days with temperature ≥ 38 °C
Description
The number of days with temperature ≥ 38 °C during an URTI episode, which was diagnosed by a GP, adjusted for sample size.
Time Frame
16 weeks
Title
WURSS-K score
Description
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.
Time Frame
16 weeks
Title
The number of subjects with one or more episode of URTI
Description
The number of subjects with one or more episode of URTI, which was diagnosed by a GP, adjusted for sample size.
Time Frame
16 weeks
Title
The number of days of absence from daycare or primary school
Description
The number of days of absence from daycare or primary school during an URTI, which was diagnosed by a GP, adjusted for sample size.
Time Frame
16 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gordon Crawford, DRCOG
Organizational Affiliation
CPS Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
CPS Research
City
Glasgow
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34895109
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.
Results Reference
derived

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The Effect of a Probiotic on Upper Respiratory Tract Infections

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