Bifidobacterium Animalis Subsp. Lactis for Lowering the Risk of Common Infections in Hospitalized Children

Respiratory Tract Infections Clinical Trial

— PROBIC II  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702766
• Other study ID #: PROBBIC II Study
• Status: Completed
• Phase: N/A
• First received: October 3, 2012
• Last updated: July 24, 2013
• Start date: December 2012

Study information

• Verified date: July 2013
• Source: Children's Hospital Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. primary completion date: July 2013
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

Inclusion Criteria:

• Children hospitalized at the Department of Paediatrics, Children's Hospital Zagreb

• Age from 1 year to 18 years

• Signed informed consent by the parents

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Communicable Diseases
• Gastrointestinal Tract Infections
• Infection
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Bifidobacterium animalis subsp. lactis

Locations

Country	Name	City	State
Croatia	Children's Hospital Zagreb	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Severity of infection	Severity of GI infections based on Vesikari scale Severity of respiratory infections according to the physician based on visual analogue scale
Primary	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	Duration of symptoms	Duration of symptoms in days