The Effect of a Probiotic on Upper Respiratory Tract Infections

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

619 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-09-01

Study Completion Date

2019-08-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Infections, Upper Respiratory Tract

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Probiotic

Group Type EXPERIMENTAL

Probiotic strain

Intervention Type DIETARY_SUPPLEMENT

Lactobacillus

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

Placebo

Interventions

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Probiotic strain

Lactobacillus

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes