Effect of Probiotics in Reducing Infections and Allergies in Young Children Starting Daycare

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Probiotics in Reducing Infections and Allergies in Young Children Starting Daycare

Conditions
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Days Absent From Daycare, Respiratory Tract Infections, Gastrointestinal Infections, Allergy

Intervention / Treatment
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* Dietary Supplement: Probiotic (2 * 10^9 cfu/day)
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Expected to start daycare between the age of 8-14 month Intervention start 0 days to 12 weeks before starting daycare Expected to start daycare from september to february (both month included) Single born Exclusion Criteria: 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: 8 Months
Maximum Age: 14 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 (2 * 10^9 cfu/d)<br>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 | Dietary Supplement: Probiotic (2 * 10^9 cfu/day)<br>* Combination of two probiotics (2 * 10^9 cfu/day) or probiotics for 6 months<br>* Other names: Lactobacillus Rhamnosus GG (LGG), 10^9 cfu/day;|
| Placebo Comparator: Placebo<br>provided as powder in a sachet, and can be added to food or drink | Dietary Supplement: Placebo<br>* Placebo for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

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 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) | 

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