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

Respiratory Tract Infections Clinical Trial

— PROBBIC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01702753
• Other study ID #: PROBBIC I Study
• Status: Completed
• Phase: N/A
• First received: October 3, 2012
• Last updated: July 24, 2013
• Start date: January 2013
• Est. completion date: April 2013

Study information

• Verified date: July 2013
• Source: Children's Hospital Zagreb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 250
• Est. completion date: April 2013
• Est. primary completion date: April 2013
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Gastrointestinal Tract Infections
• Infection
• Respiratory Tract Infections

Intervention

Dietary Supplement:
• Bifidobacterium animalis subsp. lactis

Locations

Country	Name	City	State
Croatia	Djecji vrtic Matija Gubec	Zagreb

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Zagreb

Country where clinical trial is conducted

Croatia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Infections with determined infective cause	Number of gastrointestinal and erspiratory tract infections with proven infective cause (if determined)
Primary	Common infections	Number of children with gastrointestinal tract infections defined as diarrhoea (3 or more loose or watery stools in 24 hours or increase of number of stools for more than 50% in 24 hours) or vomiting (defined by physician and not a result of other symptoms including cough or diseases including gastroesophageal reflux disease or neurological conditions) or both.; And number of children with respiratory tract infections defined as: pharyngitis, otitis, common cold, pneumonia, bronchitis and bronciolitis (all infections diagnosed by physician) Number of children with adverse events.
Secondary	Duration of symptoms	Duration of symptoms in days