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

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.

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.

Study Overview

• Status: Completed
• Conditions: Infections, Upper Respiratory Tract
• Intervention / Treatment: Dietary supplement: Placebo; Dietary supplement: Probiotic strain

• Study Type: Interventional
• Enrollment (Actual): 619
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Glasgow, United Kingdom
    • CPS Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 6 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Dietary supplement: Placebo; Placebo
Experimental: Probiotic	Dietary supplement: Probiotic strain; Lactobacillus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	16 weeks
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.	16 weeks
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.	16 weeks
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.	16 weeks
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.	16 weeks
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.	16 weeks

Collaborators and Investigators

• Sponsor: Chr Hansen
• Collaborators: Onorach Clinical; CPS Research
• Investigators: Principal Investigator: Gordon Crawford, DRCOG, CPS Research

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Actual): April 13, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: August 16, 2018
• First Submitted That Met QC Criteria: August 16, 2018
• First Posted (Actual): August 17, 2018

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Infections; Respiratory Tract Infections
• Other Study ID Numbers: HND-IM-030

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No