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

NCT01702753 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2013-07-26

No results posted yet for this study

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

Interventions

DIETARY_SUPPLEMENT

Bifidobacterium animalis subsp. lactis

Sponsors & Collaborators

  • Children's Hospital Zagreb

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2013-04-30
Completion
2013-04-30

Countries

  • Croatia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01702753 on ClinicalTrials.gov