The Effect of a Probiotic on Upper Respiratory Tract Infections

Infections, Upper Respiratory Tract Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03636191
• Other study ID #: HND-IM-030
• Status: Completed
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: August 30, 2019

Study information

• Verified date: July 2020
• Source: Chr Hansen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 619
• Est. completion date: August 30, 2019
• Est. primary completion date: April 13, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 2 Years to 6 Years

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Infections, Upper Respiratory Tract
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Probiotic strain
Lactobacillus
• Placebo
Placebo

Locations

Country	Name	City	State
United Kingdom	CPS Research	Glasgow

Sponsors (3)

Lead Sponsor	Collaborator
Chr Hansen	CPS Research, Onorach Clinical

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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