Back to resultsThe Effect of a Probiotic on Protection Against Upper Respiratory Tract Infections in Children
Primary Purpose
Upper Respiratory Tract Infection
Status
Terminated
Phase
Phase 2
Locations
Sweden
Study Type
Interventional
Intervention
probiotic
placebo
Sponsored by
About this trial
This is an interventional prevention trial for Upper Respiratory Tract Infection
Eligibility Criteria
Inclusion Criteria:
- healthy children
Exclusion Criteria:
-
Sites / Locations
- Foodfiles Sweden Ab
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
probiotic
placebo
Arm Description
dietary supplement
dietary supplement without probiotic
Outcomes
Primary Outcome Measures
upper respiratory tract infections
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01935986
Brief Title
The Effect of a Probiotic on Protection Against Upper Respiratory Tract Infections in Children
Official Title
The Effect of a Probiotic on Protection Against Upper Respiratory Tract Infections in Children
Study Type
Interventional
2. Study Status
Record Verification Date
January 2015
Overall Recruitment Status
Terminated
Why Stopped
Due to bankruptcy of the CRO company
Study Start Date
August 2013 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Probi AB
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to study the effect of a probiotic on protection against upper respiratory tract infections (URTI) in children.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Upper Respiratory Tract Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
131 (Actual)
8. Arms, Groups, and Interventions
Arm Title
probiotic
Arm Type
Experimental
Arm Description
dietary supplement
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
dietary supplement without probiotic
Intervention Type
Dietary Supplement
Intervention Name(s)
probiotic
Intervention Type
Dietary Supplement
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
upper respiratory tract infections
Time Frame
study period, 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
healthy children
Exclusion Criteria:
-
Facility Information:
Facility Name
Foodfiles Sweden Ab
City
Uppsala
ZIP/Postal Code
SE-751 83
Country
Sweden
12. IPD Sharing Statement
Learn more about this trial
The Effect of a Probiotic on Protection Against Upper Respiratory Tract Infections in Children
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