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

July 24, 2013 updated by: Children's Hospital Zagreb

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Zagreb, Croatia, 10000
        • Children's Hospital Zagreb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 year to 18 years (ADULT, CHILD)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Interventional Model: PARALLEL

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
ACTIVE_COMPARATOR: Bifidobacterium animalis subsp. lactis
Dietary supplement: Bifidobacterium animalis subsp. lactis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
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 Outcome Measures

Outcome Measure
Measure Description
Duration of symptoms
Duration of symptoms in days

Other Outcome Measures

Outcome Measure
Measure Description
Severity of infection
Severity of GI infections based on Vesikari scale Severity of respiratory infections according to the physician based on visual analogue scale

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital Zagreb

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2012

Primary Completion (ACTUAL)

July 1, 2013

Study Registration Dates

First Submitted

October 3, 2012

First Submitted That Met QC Criteria

October 5, 2012

First Posted (ESTIMATE)

October 8, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

July 26, 2013

Last Update Submitted That Met QC Criteria

July 24, 2013

Last Verified

July 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PROBBIC II Study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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