Completed

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

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What is being tested

Bifidobacterium animalis subsp. lactis

Dietary Supplement
Who is being recruted

Infections

+ Respiratory Tract Diseases

+ Respiratory Tract Infections

From 1 to 7 Years
+8 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Placebo-Controlled
Interventional
Study Start: January 2013
See protocol details

Summary

Principal SponsorChildren's Hospital Zagreb
Last updated: July 26, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: January 1, 2013

Actual date on which the first participant was enrolled.

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).

Principal SponsorChildren's Hospital Zagreb
Last updated: July 26, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

250 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 1 to 7 Years

Range of ages for which participants are eligible to join.

Conditions

Pathology

InfectionsRespiratory Tract DiseasesRespiratory Tract Infections

Criteria

4 inclusion criteria required to participate
Age from 1 year to 7 years

Attendance at daycare centers: > 3 days per week

Healthy children attending day care at kindergartens located in the Zagreb's city centre

Signed informed consent by the parents

4 exclusion criteria prevent from participating
Immunodeficiency

Neoplasms

Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to study start)

Severe chronic disorders

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

50% chance of being blinded to the placebo group

Treatment Groups

Group I

Active Comparator

Group II

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Djecji vrtic Matija Gubec

Zagreb, CroatiaOpen Djecji vrtic Matija Gubec in Google Maps
CompletedOne Study Center