Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers (PROBBIC)
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).
Gastrointestinal Tract Infections
Respiratory Tract Infections
Dietary Supplement: Bifidobacterium animalis subsp. lactis
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
|Official Title:||Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers - Randomized, Double Blind, Placebo Controlled Study|
- Common infections [ Designated as safety issue: Yes ]
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.
- Duration of symptoms [ Designated as safety issue: Yes ]Duration of symptoms in days
- Infections with determined infective cause [ Designated as safety issue: Yes ]Number of gastrointestinal and erspiratory tract infections with proven infective cause (if determined)
|Study Start Date:||January 2013|
|Study Completion Date:||April 2013|
|Primary Completion Date:||April 2013 (Final data collection date for primary outcome measure)|
|Active Comparator: Bifidobacterium animalis subsp. lactis||Dietary Supplement: Bifidobacterium animalis subsp. lactis|
|Placebo Comparator: Placebo|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01702753
|Djecji vrtic Matija Gubec|
|Zagreb, Croatia, 10000|