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| ID | Type | Description | Link |
|---|---|---|---|
| H-3-2013-064 | Other Grant/Funding Number | The Danish Council for Strategic Research |
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Changes in study design
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| Name | Class |
|---|---|
| The Danish Council for Strategic Research | OTHER |
| Chr Hansen | INDUSTRY |
| Technical University of Denmark | OTHER |
| University of Bergen |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| probiotic (10^9 cfu/day) | Experimental | 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. |
|
| probiotic (10^8 cfu/day) | Experimental | 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. |
|
| Placebo | Placebo Comparator | provided as powder in a sachet which can be added to food or drink. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic (10^9 CFU/day) | Dietary Supplement |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of days absent from day care due to respiratory and gastrointestinal infections | Recorded weekly by the parents using web-based questionnaires | Up to 6 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in biological markers for the immune system | 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Section of Paediatric and International nutrition, Department of Nutrition, Exercise and Sports, Faculty of Science, University of Copenhagen | Frederiksberg | 1958 | Denmark |
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| OTHER |
| Odense University Hospital | OTHER |
| Statens Serum Institut | OTHER |
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| Probiotic (10^8 CFU/day) | Dietary Supplement |
|
|
| Placebo | Other |
|
| 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. | 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 | Up to 6 month |
| Fever | Number of days with fever Recorded by the parents using web-based questionnaires | Up to 6 month |
| Antibiotic use | Number of treatments with antibiotics during the intervention period Recorded weekly by the parents using web-based questionnires | 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 | 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 | 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 | 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 | Up to 6 month |
| Change from baseline in Thymus size | Change in thymic size during intervention period will be evaluated using ultraound | At baseline and after 6 mo (end of intervention) |
Analysis of biological material investigating the effect on the gastrointestinal tract. |
| 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 | At baseline and after 6 mo |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D006967 | Hypersensitivity |
| D007239 | Infections |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D019936 | Probiotics |
| ID | Term |
|---|---|
| D019587 | Dietary Supplements |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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