Effect of Probiotics in Reducing Infections and Allergies in Young Children During the Complementary Feeding Period

Study Overview
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Brief Summary
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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.

Official Title
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The Effect of Probiotics in Reducing Infections and Allergic Manifestations in Young Children During the Complementary Feeding Period

Conditions
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Days Absent From Day Care, Respiratory Tract Infections, Gastrointestinal Infections, Allergy

Intervention / Treatment
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* Dietary Supplement: Probiotic (10^9 CFU/day)
* Dietary Supplement: Probiotic (10^8 CFU/day)
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 9 Months
Maximum Age: 13 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: probiotic (10^9 cfu/day)<br>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)<br> <br> * Other names: Bifidobacterium animalis ssp. Lactis (BB12);|
| Experimental: probiotic (10^8 cfu/day)<br>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)<br> <br> * Other names: Bifidobacterium animalis ssp. Lactis (BB12);|
| Placebo Comparator: Placebo<br>provided as powder in a sachet which can be added to food or drink. | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microbiota, Infections, Allergy, Immune function, infant