Bifidobacterium Animalis Subsp. Lactis for Lowering the Risk of Common Infections in Hospitalized Children
NCT ID: NCT01702766
Last Updated: 2013-07-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
INTERVENTIONAL
2012-12-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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PARALLEL
PREVENTION
Study Groups
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Bifidobacterium animalis subsp. lactis
Bifidobacterium animalis subsp. lactis
Placebo
No interventions assigned to this group
Interventions
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Bifidobacterium animalis subsp. lactis
Eligibility Criteria
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Inclusion Criteria
* Age from 1 year to 18 years
* Signed informed consent by the parents
Exclusion Criteria
* 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
1 Year
18 Years
ALL
No
Sponsors
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Children's Hospital Zagreb
OTHER
Responsible Party
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Locations
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Children's Hospital Zagreb
Zagreb, , Croatia
Countries
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References
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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.
Other Identifiers
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PROBBIC II Study
Identifier Type: -
Identifier Source: org_study_id
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