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NCT01935986 Clinical Trial

The Effect of a Probiotic on Protection Against Upper Respiratory Tract Infections in Children

Upper Respiratory Tract Infection Clinical Trial

Official title:
The Effect of a Probiotic on Protection Against Upper Respiratory Tract Infections in Children

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01935986
Other study ID # U-12-032
Secondary ID
Status Terminated
Phase Phase 2
First received August 28, 2013
Last updated November 30, 2015
Start date August 2013
Est. completion date December 2014

Study information
Verified date January 2015
Source Probi AB
Contact n/a
Is FDA regulated No
Health authority Sweden: Ethics Committee
Study type Interventional

Clinical Trial Summary

The purpose of this study is to study the effect of a probiotic on protection against upper respiratory tract infections (URTI) in children.

Recruitment information / eligibility
Status Terminated
Enrollment 131
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 1 Year to 6 Years
Eligibility Inclusion Criteria:

- healthy children

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• probiotic

• placebo

Locations
Country Name City State
Sweden Foodfiles Sweden Ab Uppsala

Sponsors (1)
Lead Sponsor Collaborator
Probi AB

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary upper respiratory tract infections study period, 12 weeks No
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