Allergy, Days Absent From Day Care, Gastrointestinal Infections, Respiratory Tract Infections
Conditions
Keywords
Infections, Allergy, Immune function, Microbiota, infant
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.
Interventions
DIETARY_SUPPLEMENTProbiotic (10^9 CFU/day)
DIETARY_SUPPLEMENTProbiotic (10^8 CFU/day)
OTHERPlacebo
Sponsors
The Danish Council for Strategic Research
Chr Hansen
Technical University of Denmark
University of Bergen
Odense University Hospital
Statens Serum Institut
University of Copenhagen
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
9 Months to 13 Months
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of days absent from day care due to respiratory and gastrointestinal infections | Up to 6 month | Recorded weekly by the parents using web-based questionnaires |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Antibiotic use | Up to 6 month | Number of treatments with antibiotics during the intervention period Recorded weekly by the parents using web-based questionnires |
| Parental absence from work due to illness of the child | 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 |
| Medical visits | 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 |
| Change from baseline in Thymus size | At baseline and after 6 mo (end of intervention) | Change in thymic size during intervention period will be evaluated using ultraound |
| Acute upper respiratory tract infections | 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. |
| Acute lower respiratory infections | 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. |
| Gastrointestinal infections | 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 |
| Fever | Up to 6 month | Number of days with fever Recorded by the parents using web-based questionnaires |
| Allergies | 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 |
| Absence from day care due to illness other than infections | 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Biological markers of allergy | At baseline and after 6 mo | analysis of biological samples investigating the effect on allergy by biological markers at baseline and at 6 mo |
| Change from baseline in biological markers for the immune system | At baseline and after 6 mo | Analysis of biological material investigating the effect on the immune system by biological markers . |
| Change from baseline in biological markers for gastro-intestinal tract | At baseline and after 6 mo | Analysis of biological material investigating the effect on the gastrointestinal tract. |
Countries
Denmark
Outcome results
None listed