Children's Hospital Zagreb
Zagreb, 10000, Croatia
NCT Number: NCT01702766
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.
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Notify Me1 year–18 year
All sexes
Interventional
Not applicable
Zagreb, 10000, Croatia
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 in days
Severity of GI infections based on Vesikari scale Severity of respiratory infections according to the physician based on visual analogue scale
Children's Hospital Zagreb
Other
Acronym: PROBIC II
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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