Bifidobacterium Animalis Subsp. Lactis for Lowering the Risk of Common Infections in Hospitalized Children

Study Overview
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Brief Summary
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Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be defined as infections which develop more than 48 hours after admission and they are not present or incubating on admission This study is a prospective, randomized, double blind, placebo- controlled parallel study in children hospitalized at Children's hospital Zagreb. 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. The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) probiotic per serving. The placebo product is an identical product except for the absence of probiotics. The study includes an intervention period lasting the length of the hospital stay. The study product will be consumed daily in the morning together with breakfast. The consumption of the study products will be taken under the surveillance of the physician. Data on infections will be diagnosed by a physician and recorded in a CRF. The incidence of infections will be analyzed based on the information recorded in the CRF.

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: Children hospitalized at the Department of Paediatrics, Children's Hospital Zagreb Age from 1 year to 18 years Signed informed consent by the parents Exclusion Criteria: Immunodeficiency Infants from neonatal period until 1 year of age Re-hospitalisation (readmission in a hospital within one month) Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to hospitalization) Neoplasms Severe chronic diseases Hospitalization shorter than 3 days

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 18 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
Intervention Model: Parallel Assignment


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 in children | Number of children with common infections (gastrointestinal and respiratory infections): 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. 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 |  |