Bifidobacterium Animalis Subsp. Lactis for Lowering the Risk of Common Infections in Hospitalized Children (PROBIC II)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Zagreb
ClinicalTrials.gov Identifier:
NCT01702766
First received: October 3, 2012
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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.


Condition Intervention
Gastrointestinal Tract Infections
Respiratory Tract Infections
Dietary Supplement: Bifidobacterium animalis subsp. lactis

Study Type: Interventional
Study Design: Intervention Model: Parallel Assignment
Primary Purpose: Prevention

Further study details as provided by Children's Hospital Zagreb:

Primary Outcome Measures:
  • 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.



Secondary Outcome Measures:
  • Duration of symptoms [ Designated as safety issue: Yes ]
    Duration of symptoms in days


Other Outcome Measures:
  • 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)
Arms Assigned Interventions
Active Comparator: Bifidobacterium animalis subsp. lactis Dietary Supplement: Bifidobacterium animalis subsp. lactis
Placebo Comparator: Placebo

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01702766

Locations
Croatia
Children's Hospital Zagreb
Zagreb, Croatia, 10000
Sponsors and Collaborators
Children's Hospital Zagreb
  More Information

No publications provided

Responsible Party: Children's Hospital Zagreb
ClinicalTrials.gov Identifier: NCT01702766     History of Changes
Other Study ID Numbers: PROBBIC II Study
Study First Received: October 3, 2012
Last Updated: July 24, 2013
Health Authority: Croatia: Ministry of Health and Social Care

Additional relevant MeSH terms:
Respiratory Tract Infections
Infection
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 19, 2014