Bifidobacterium Animalis Subsp. Lactis for Lowering the Risk of Common Infections in Hospitalized Children (PROBIC II)
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.
Gastrointestinal Tract Infections
Respiratory Tract Infections
Dietary Supplement: Bifidobacterium animalis subsp. lactis
|Study Design:||Intervention Model: Parallel Assignment
Primary Purpose: Prevention
- Common infections in children [ Designated as safety issue: Yes ]
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.
- Duration of symptoms [ Designated as safety issue: Yes ]Duration of symptoms in days
- Severity of infection [ Designated as safety issue: Yes ]Severity of GI infections based on Vesikari scale Severity of respiratory infections according to the physician based on visual analogue scale
|Study Start Date:||December 2012|
|Primary Completion Date:||July 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: NCT01702766
|Children's Hospital Zagreb|
|Zagreb, Croatia, 10000|