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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01702766
Recruitment Status : Completed
First Posted : October 8, 2012
Last Update Posted : July 26, 2013
Information provided by (Responsible Party):
Children's Hospital Zagreb

Brief 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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Tract Infections Respiratory Tract Infections Dietary Supplement: Bifidobacterium animalis subsp. lactis Not Applicable

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Study Type : Interventional  (Clinical Trial)
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Study Start Date : December 2012
Actual Primary Completion Date : July 2013

Arm Intervention/treatment
Active Comparator: Bifidobacterium animalis subsp. lactis Dietary Supplement: Bifidobacterium animalis subsp. lactis
Placebo Comparator: Placebo

Primary Outcome Measures :
  1. 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 :
  1. Duration of symptoms
    Duration of symptoms in days

Other Outcome Measures:
  1. Severity of infection
    Severity of GI infections based on Vesikari scale Severity of respiratory infections according to the physician based on visual analogue scale

Information from the National Library of Medicine

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, Learn About Clinical Studies.

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01702766

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Children's Hospital Zagreb
Zagreb, Croatia, 10000
Sponsors and Collaborators
Children's Hospital Zagreb

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Children's Hospital Zagreb Identifier: NCT01702766    
Other Study ID Numbers: PROBBIC II Study
First Posted: October 8, 2012    Key Record Dates
Last Update Posted: July 26, 2013
Last Verified: July 2013
Additional relevant MeSH terms:
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Communicable Diseases
Respiratory Tract Infections
Respiratory Tract Diseases