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

NCT ID: NCT01702753

Last Updated: 2013-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 250 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2013-04-30

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).

Conditions

Gastrointestinal Tract Infections; Respiratory Tract Infections

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Bifidobacterium animalis subsp. lactis

Group Type: ACTIVE_COMPARATOR

Bifidobacterium animalis subsp. lactis

Intervention Type: DIETARY_SUPPLEMENT

Placebo

Group Type: PLACEBO_COMPARATOR

No interventions assigned to this group

Interventions

Bifidobacterium animalis subsp. lactis

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Zagreb

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Djecji vrtic Matija Gubec

Zagreb, , Croatia

Countries

Croatia

References

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.

Reference Type: DERIVED

PMID: 26031908 (View on PubMed)

Other Identifiers

PROBBIC I Study

Identifier Type: -

Identifier Source: org_study_id