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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Zagreb
ClinicalTrials.gov Identifier:
NCT01702753
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 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 Intervention
Gastrointestinal Tract Infections
Respiratory Tract Infections
Dietary Supplement: Bifidobacterium animalis subsp. lactis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Common infections [ Designated as safety issue: Yes ]

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


Other Outcome Measures:
  • Infections with determined infective cause [ Designated as safety issue: Yes ]
    Number of gastrointestinal and erspiratory tract infections with proven infective cause (if determined)


Estimated Enrollment: 250
Study Start Date: January 2013
Study Completion Date: April 2013
Primary Completion Date: April 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 7 Years
Genders Eligible for Study:   Both
Criteria

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
  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: NCT01702753

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

No publications provided

Responsible Party: Children's Hospital Zagreb
ClinicalTrials.gov Identifier: NCT01702753     History of Changes
Other Study ID Numbers: PROBBIC I 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:
Communicable Diseases
Infection
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 25, 2014