Clinical trial NCT01702753: Bifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Tract Infections
Respiratory Tract Infections
Lead sponsor: Children's Hospital Zagreb
Sponsor class: OTHER
First posted: 2012-10-08
Enrollment: 250
Sex: ALL
Minimum age (years): 1
Maximum age (years): 7
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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).


Eligibility 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

Primary outcomes:
measure: Common infections
Secondary outcomes:
measure: Duration of symptoms
Other outcomes:
measure: Infections with determined infective cause
Locations:
city: Zagreb
country: Croatia
facility: Djecji vrtic Matija Gubec
Study officials:
References:
citation: 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.