Bifidobacterium Animalis Subsp. Lactis for Lowering the Risk of Common Infections in Hospitalized Children
PROBIC II
1 other identifier
interventional
N/A
1 country
1
Brief Summary
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.
Trial Health
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 3, 2012
CompletedFirst Posted
Study publicly available on registry
October 8, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedJuly 26, 2013
July 1, 2013
7 months
October 3, 2012
July 24, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Duration of symptoms
Other Outcomes (1)
Severity of infection
Study Arms (2)
Bifidobacterium animalis subsp. lactis
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Children hospitalized at the Department of Paediatrics, Children's Hospital Zagreb
- Age from 1 year to 18 years
- Signed informed consent by the parents
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Zagreb
Zagreb, 10000, Croatia
Related Publications (1)
Hojsak I, Tokic Pivac V, Mocic Pavic A, Pasini AM, Kolacek S. Bifidobacterium animalis subsp. lactis fails to prevent common infections in hospitalized children: a randomized, double-blind, placebo-controlled study. Am J Clin Nutr. 2015 Mar;101(3):680-4. doi: 10.3945/ajcn.114.102004. Epub 2015 Jan 7.
PMID: 25733653DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 3, 2012
First Posted
October 8, 2012
Study Start
December 1, 2012
Primary Completion
July 1, 2013
Last Updated
July 26, 2013
Record last verified: 2013-07