Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers (PROBBIC)

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: NCT01702753
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 infections (gastrointestinal and respiratory) in healthy children who attend day care centre

This study is a prospective, randomized, double blind, placebo- controlled parallel study in healthy children attending day care centers.

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 and absence from day care due to infections.

The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) of probiotic per serving. The placebo product is an identical product except for the absence of probiotics.

The study includes 3 months (90 days) of intervention period. The study product will be consumed daily in the evening together with a meal.

The consumption of the study products will be taken under the surveillance of the parents.

During the entire intervention period the subjects are not allowed to consume any probiotic products other than the study products supplied to them by the study personnel.

Data on infections will be recorded in a diary, filled in and administered by the parents and diary recorded by referring physician (on-call log).

All infections are to be diagnosed by the local physician. The incidence of infections will be analyzed based on the information recorded in the diaries (parent's & physician's).

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers - Randomized, Double Blind, Placebo Controlled Study
Study Start Date : January 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 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

    Number of children with 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.

    And number of children with 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. Infections with determined infective cause
    Number of gastrointestinal and erspiratory tract infections with proven infective cause (if determined)

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Ages Eligible for Study:   1 Year to 7 Years   (Child)
Sexes Eligible for Study:   All

Inclusion Criteria:

  • Healthy children attending day care at kindergartens located in the Zagreb's city centre
  • Age from 1 year to 7 years
  • Attendance at daycare centers: > 3 days per week
  • Signed informed consent by the parents

Exclusion Criteria:

  • Immunodeficiency
  • Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to study start)
  • Neoplasms
  • Severe chronic disorders

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): NCT01702753

Djecji vrtic Matija Gubec
Zagreb, Croatia, 10000
Sponsors and Collaborators
Children's Hospital Zagreb

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Children's Hospital Zagreb Identifier: NCT01702753     History of Changes
Other Study ID Numbers: PROBBIC I Study
First Posted: October 8, 2012    Key Record Dates
Last Update Posted: July 26, 2013
Last Verified: July 2013

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