- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02032056
Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period (ProbiComp)
The Effect of Probiotics in Reducing Infections and Allergic Manifestations in Young Children During the Complementary Feeding Period
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Frederiksberg, Denmark, 1958
- Section of Paediatric and International nutrition, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 9 - 12 1/2 month at intervention start
- Start in daycare 4 +/- 2 weeks after intervention start
- Single born
Exclusion Criteria:
- Children born before 37th gestational week
- Children with a birth weight < 2500 g
- Children suffering from severe chronic illness
- Children receiving regular medication
- Children who have received antibiotics within a month before intervention start
- Children whose parents do not speak Danish
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: probiotic (10^9 cfu/day)
Daily intake of bifidobacterium animalis ssp.
Lactis (BB12), 10^9 cfu/day, provided as powder in a sachet which can be added to food or drink.
|
Other Names:
|
Experimental: probiotic (10^8 cfu/day)
Daily intake of bifidobacterium animalis ssp.
Lactis (BB12), 10^8 cfu/day, provided as powder in a sachet which can be added to food or drink.
|
Other Names:
|
Placebo Comparator: Placebo
provided as powder in a sachet which can be added to food or drink.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of days absent from day care due to respiratory and gastrointestinal infections
Time Frame: Up to 6 month
|
Recorded weekly by the parents using web-based questionnaires
|
Up to 6 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Acute upper respiratory tract infections
Time Frame: Up to 6 month
|
Number of days with acute upper respiratory tract infections (URTI); Number of children with at least 1 episode of URTI; Number of children with at least 3 episodes of URTI; Number of URTI episodes/child/year; Duration of URTI episodes (days); Additionally,symptoms of cold (defined as 2 days with runny/stuffy nose or cough) Recorded by the parents daily/weekly using web-based questionnaires. |
Up to 6 month
|
Acute lower respiratory infections
Time Frame: Up to 6 month
|
Number of children with at least 1 episode of a lower respiratory tract infection (LRTI). LRTI include bronchitis and pneumonia Recorded by the parents weekly using web-based questionnaires. |
Up to 6 month
|
Gastrointestinal infections
Time Frame: Up to 6 month
|
Number of children with at least 1 episode of diarrhea; Duration of episodes with diarrhea(days); Number of episodes/child/year with diarrhea; Number of days with vomiting. Recorded by the parents daily using web-based questionnaires |
Up to 6 month
|
Fever
Time Frame: Up to 6 month
|
Number of days with fever Recorded by the parents using web-based questionnaires |
Up to 6 month
|
Absence from day care due to illness other than infections
Time Frame: Up to 6 month
|
Number of days the child is absent from day care due to illness, which is not due to infections. Recorded by the parents weekly using web-based questionnaires |
Up to 6 month
|
Parental absence from work due to illness of the child
Time Frame: Up to 6 month
|
Number of days a parent is absent from work due to illness of the child (infections and other illnesses, respectively) Recorded by the parents weekly using web-based questionnaires |
Up to 6 month
|
Medical visits
Time Frame: Up to 6 month
|
Number of visits to a doctor due to infections and other illnesses, respectively. Recorded by the parents using web-based questionnaires |
Up to 6 month
|
Antibiotic use
Time Frame: Up to 6 month
|
Number of treatments with antibiotics during the intervention period Recorded weekly by the parents using web-based questionnires |
Up to 6 month
|
Allergies
Time Frame: Up to 6 month
|
Number of children developing allergies during the intervention period (asthma, allergic rhinitis, atopic dermatitis, food allergies); Age for diagnosis of allergies; Use of medication due to allergies. Recorded by the parents monthly using web-based questionnaires |
Up to 6 month
|
Change from baseline in Thymus size
Time Frame: At baseline and after 6 mo (end of intervention)
|
Change in thymic size during intervention period will be evaluated using ultraound
|
At baseline and after 6 mo (end of intervention)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change from baseline in biological markers for the immune system
Time Frame: At baseline and after 6 mo
|
Analysis of biological material investigating the effect on the immune system by biological markers .
|
At baseline and after 6 mo
|
Change from baseline in biological markers for gastro-intestinal tract
Time Frame: At baseline and after 6 mo
|
Analysis of biological material investigating the effect on the gastrointestinal tract.
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At baseline and after 6 mo
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Change from baseline in Biological markers of allergy
Time Frame: At baseline and after 6 mo
|
analysis of biological samples investigating the effect on allergy by biological markers at baseline and at 6 mo
|
At baseline and after 6 mo
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H-3-2013-064 (Other Grant/Funding Number: The Danish Council for Strategic Research)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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