Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers

Study Overview
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Brief Summary
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Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common infections (gastrointestinal and respiratory) in healthy children who attend day care centre This study is a prospective, randomized, double blind, placebo- controlled parallel study in healthy children attending day care centers. The study will investigate the effect of supplementation with the probiotic strain Bifidobacterium animalis subsp. lactis on the incidence and duration of gastrointestinal and respiratory infections and absence from day care due to infections. The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) of probiotic per serving. The placebo product is an identical product except for the absence of probiotics. The study includes 3 months (90 days) of intervention period. The study product will be consumed daily in the evening together with a meal. The consumption of the study products will be taken under the surveillance of the parents. During the entire intervention period the subjects are not allowed to consume any probiotic products other than the study products supplied to them by the study personnel. Data on infections will be recorded in a diary, filled in and administered by the parents and diary recorded by referring physician (on-call log). All infections are to be diagnosed by the local physician. The incidence of infections will be analyzed based on the information recorded in the diaries (parent's & physician's).

Official Title
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Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers - Randomized, Double Blind, Placebo Controlled Study

Conditions
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Gastrointestinal Tract Infections, Respiratory Tract Infections

Intervention / Treatment
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* Dietary Supplement: Bifidobacterium animalis subsp. lactis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy children attending day care at kindergartens located in the Zagreb's city centre Age from 1 year to 7 years Attendance at daycare centers: > 3 days per week Signed informed consent by the parents Exclusion Criteria: Immunodeficiency Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to study start) Neoplasms Severe chronic disorders

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 7 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| Active Comparator: Bifidobacterium animalis subsp. lactis<br> | Dietary Supplement: Bifidobacterium animalis subsp. lactis<br> <br> |
| Placebo Comparator: Placebo<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Common infections | Number of children with gastrointestinal tract infections defined as diarrhoea (3 or more loose or watery stools in 24 hours or increase of number of stools for more than 50% in 24 hours) or vomiting (defined by physician and not a result of other symptoms including cough or diseases including gastroesophageal reflux disease or neurological conditions) or both. And number of children with respiratory tract infections defined as: pharyngitis, otitis, common cold, pneumonia, bronchitis and bronciolitis (all infections diagnosed by physician) Number of children with adverse events. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of symptoms | Duration of symptoms in days |  |