An interventional study of Probiotic (10^9 CFU/day) and Probiotic (10^8 CFU/day) in Days Absent From Day Care, Respiratory Tract Infections and Gastrointestinal Infections, sponsored by University of Copenhagen. Terminated at 1 site in Denmark. Open to participants aged 9 Months to 13 Months, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-05-08.
Sponsored by University of Copenhagen · Not applicable, Interventional, and Prevention
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 40 is below the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →University of Copenhagen is the lead sponsor of 450 studies on the registry; 61 are open to participants now.
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Exclusion Criteria:
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.
Dietary Supplement: Probiotic (10^9 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.
Dietary Supplement: Probiotic (10^8 CFU/day)
provided as powder in a sachet which can be added to food or drink.
Other: Placebo
Also known as: Bifidobacterium animalis ssp. Lactis (BB12)
Also known as: Bifidobacterium animalis ssp. Lactis (BB12)
Number of days absent from day care due to respiratory and gastrointestinal infections
Recorded weekly by the parents using web-based questionnaires
Time frame: Up to 6 month
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.
Time frame: Up to 6 month
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.
Time frame: Up to 6 month
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
Time frame: Up to 6 month
Fever
Number of days with fever Recorded by the parents using web-based questionnaires
Time frame: Up to 6 month
Antibiotic use
Number of treatments with antibiotics during the intervention period Recorded weekly by the parents using web-based questionnires
Time frame: Up to 6 month
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
Time frame: Up to 6 month
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
Time frame: Up to 6 month
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
Time frame: Up to 6 month
Medical visits
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
Change from baseline in Thymus size
Change in thymic size during intervention period will be evaluated using ultraound
Time frame: At baseline and after 6 mo (end of intervention)
Change from baseline in biological markers for the immune system
Analysis of biological material investigating the effect on the immune system by biological markers .
Time frame: At baseline and after 6 mo
Change from baseline in biological markers for gastro-intestinal tract
Analysis of biological material investigating the effect on the gastrointestinal tract.
Time frame: At baseline and after 6 mo
Change from baseline in Biological markers of allergy
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
This study is terminated, as verified in May 2018. You cannot join it, but the record below documents what was studied.
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University of Copenhagen