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| ID | Type | Description | Link |
|---|---|---|---|
| H-4-2014-032 | Other Grant/Funding Number | The Danish Council for Strategic Research |
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| Name | Class |
|---|---|
| The Danish Council for Strategic Research | OTHER |
| Novonesis | INDUSTRY |
| Technical University of Denmark | OTHER |
| University of Bergen |
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The aim of the intervention is to examine the effect of a combination of the two bacterial strains BB-12 and LGG, provided for 6 month, on the prevalence of infections and allergic manifestations in small children, and how a combination of BB-12 and LGG affects the immune system, gastrointestinal tract and the microbiota. Children are enrolled during 2 winter seasons.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Probiotic (2 * 10^9 cfu/d) | Experimental | Daily intake of bifidobacterium animalis ssp. Lactis (BB12) and Lactobacillus Rhamnosus GG (LGG) in a dosage of 10^9 cfu/day of each strain. The probiotics are provided as powder in a sachet, and can be added to food or drink |
|
| Placebo | Placebo Comparator | provided as powder in a sachet, and can be added to food or drink |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Probiotic (2 * 10^9 cfu/day) | Dietary Supplement | Combination of two probiotics (2 * 10^9 cfu/day) or probiotics for 6 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of days absent from daycare 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30790361 | Derived | Schmidt RM, Pilmann Laursen R, Bruun S, Larnkjaer A, Molgaard C, Michaelsen KF, Host A. Probiotics in late infancy reduce the incidence of eczema: A randomized controlled trial. Pediatr Allergy Immunol. 2019 May;30(3):335-340. doi: 10.1111/pai.13018. Epub 2019 Feb 21. | |
| 28818050 | Derived | Laursen MF, Laursen RP, Larnkjaer A, Michaelsen KF, Bahl MI, Licht TR. Administration of two probiotic strains during early childhood does not affect the endogenous gut microbiota composition despite probiotic proliferation. BMC Microbiol. 2017 Aug 17;17(1):175. doi: 10.1186/s12866-017-1090-7. |
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| 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 |
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| OTHER |
| Odense University Hospital | OTHER |
| Statens Serum Institut | OTHER |
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| Placebo | Dietary Supplement | Placebo for 6 months |
|
| 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 questionnaires | 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 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 ultrasound | 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 |
| D019602 |
| Food and Beverages |