PROBBICBifidobacterium Animalis Subsp. Lactis in Prevention of Common Infections in Healthy Children Attending Day Care Centers - Randomized, Double Blind, Placebo Controlled Study
Bifidobacterium animalis subsp. lactis
Infections
+ Respiratory Tract Diseases
+ Respiratory Tract Infections
Prevention Study
Summary
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).
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.250 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Prevention Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
Active ComparatorGroup II
PlaceboStudy 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