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

Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers - Randomized, Double Blind, Placebo Controlled Study

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).

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Gastrointestinal Tract Infections
• Intervention / Treatment: Dietary supplement: Bifidobacterium animalis subsp. lactis

• Study Type: Interventional
• Enrollment (Anticipated): 250
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Croatia
  • Zagreb, Croatia, 10000
    • Djecji vrtic Matija Gubec

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 7 years (Child)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

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

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

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

Other Outcome Measures

Outcome Measure	Measure Description
Infections with determined infective cause	Number of gastrointestinal and erspiratory tract infections with proven infective cause (if determined)

Collaborators and Investigators

• Sponsor: Children's Hospital Zagreb

Publications and helpful links

General Publications

• Hojsak I, Mocic Pavic A, Kos T, Dumancic J, Kolacek S. Bifidobacterium animalis subsp. lactis in prevention of common infections in healthy children attending day care centers - Randomized, double blind, placebo-controlled study. Clin Nutr. 2016 Jun;35(3):587-91. doi: 10.1016/j.clnu.2015.05.004. Epub 2015 May 19.

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): April 1, 2013
• Study Completion (Actual): April 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: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: PROBBIC I Study