Back to resultsEffect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period (ProbiComp)
Primary Purpose
Days Absent From Day Care, Respiratory Tract Infections, Gastrointestinal Infections
Status
Terminated
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Probiotic (10^9 CFU/day)
Probiotic (10^8 CFU/day)
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Days Absent From Day Care focused on measuring Infections, Allergy, Immune function, Microbiota, infant
Eligibility Criteria
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
Sites / Locations
- Section of Paediatric and International nutrition, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
probiotic (10^9 cfu/day)
probiotic (10^8 cfu/day)
Placebo
Arm Description
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.
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.
provided as powder in a sachet which can be added to food or drink.
Outcomes
Primary Outcome Measures
Number of days absent from day care due to respiratory and gastrointestinal infections
Recorded weekly by the parents using web-based questionnaires
Secondary Outcome Measures
Acute upper respiratory tract infections
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.
Acute lower respiratory infections
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.
Gastrointestinal infections
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
Fever
Number of days with fever
Recorded by the parents using web-based questionnaires
Antibiotic use
Number of treatments with antibiotics during the intervention period
Recorded weekly by the parents using web-based questionnires
Allergies
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
Absence from day care due to illness other than infections
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
Parental absence from work due to illness of the child
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
Medical visits
Number of visits to a doctor due to infections and other illnesses, respectively.
Recorded by the parents using web-based questionnaires
Change from baseline in Thymus size
Change in thymic size during intervention period will be evaluated using ultraound
Full Information
NCT ID
NCT02032056
First Posted
November 20, 2013
Last Updated
May 2, 2018
Sponsor
University of Copenhagen
Collaborators
The Danish Council for Strategic Research, Chr Hansen, Technical University of Denmark, University of Bergen, Odense University Hospital, Statens Serum Institut
1. Study Identification
Unique Protocol Identification Number
NCT02032056
Brief Title
Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period
Acronym
ProbiComp
Official Title
The Effect of Probiotics in Reducing Infections and Allergic Manifestations in Young Children During the Complementary Feeding Period
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Terminated
Why Stopped
Changes in study design
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Copenhagen
Collaborators
The Danish Council for Strategic Research, Chr Hansen, Technical University of Denmark, University of Bergen, Odense University Hospital, Statens Serum Institut
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of the intervention is to examine the effect of the bacterial strain BB-12, provided for 6 mo, on the prevalence of infections and allergic manifestations in small children, and how BB-12 affects the immune system, the gastrointestinal tract and the microbiota. Children are enrolled during 2 winter seasons.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Days Absent From Day Care, Respiratory Tract Infections, Gastrointestinal Infections, Allergy
Keywords
Infections, Allergy, Immune function, Microbiota, infant
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
probiotic (10^9 cfu/day)
Arm Type
Experimental
Arm Description
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.
Arm Title
probiotic (10^8 cfu/day)
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
provided as powder in a sachet which can be added to food or drink.
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic (10^9 CFU/day)
Other Intervention Name(s)
Bifidobacterium animalis ssp. Lactis (BB12)
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic (10^8 CFU/day)
Other Intervention Name(s)
Bifidobacterium animalis ssp. Lactis (BB12)
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of days absent from day care due to respiratory and gastrointestinal infections
Description
Recorded weekly by the parents using web-based questionnaires
Time Frame
Up to 6 month
Secondary Outcome Measure Information:
Title
Acute upper respiratory tract infections
Description
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.
Time Frame
Up to 6 month
Title
Acute lower respiratory infections
Description
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.
Time Frame
Up to 6 month
Title
Gastrointestinal infections
Description
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
Time Frame
Up to 6 month
Title
Fever
Description
Number of days with fever
Recorded by the parents using web-based questionnaires
Time Frame
Up to 6 month
Title
Antibiotic use
Description
Number of treatments with antibiotics during the intervention period
Recorded weekly by the parents using web-based questionnires
Time Frame
Up to 6 month
Title
Allergies
Description
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
Time Frame
Up to 6 month
Title
Absence from day care due to illness other than infections
Description
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
Time Frame
Up to 6 month
Title
Parental absence from work due to illness of the child
Description
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
Time Frame
Up to 6 month
Title
Medical visits
Description
Number of visits to a doctor due to infections and other illnesses, respectively.
Recorded by the parents using web-based questionnaires
Time Frame
Up to 6 month
Title
Change from baseline in Thymus size
Description
Change in thymic size during intervention period will be evaluated using ultraound
Time Frame
At baseline and after 6 mo (end of intervention)
Other Pre-specified Outcome Measures:
Title
Change from baseline in biological markers for the immune system
Description
Analysis of biological material investigating the effect on the immune system by biological markers .
Time Frame
At baseline and after 6 mo
Title
Change from baseline in biological markers for gastro-intestinal tract
Description
Analysis of biological material investigating the effect on the gastrointestinal tract.
Time Frame
At baseline and after 6 mo
Title
Change from baseline in Biological markers of allergy
Description
analysis of biological samples investigating the effect on allergy by biological markers at baseline and at 6 mo
Time Frame
At baseline and after 6 mo
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Months
Maximum Age & Unit of Time
13 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Section of Paediatric and International nutrition, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen
City
Frederiksberg
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
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Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period
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