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

NCT01702753 | Completed DMC

• 1 other identifier: PROBBIC I Study
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Duration of symptoms

Other Outcomes (1)

• Infections with determined infective cause

Study Arms (2)

Bifidobacterium animalis subsp. lactis

ACTIVE COMPARATOR

Dietary Supplement: Bifidobacterium animalis subsp. lactis

Placebo

PLACEBO COMPARATOR

Interventions

Bifidobacterium animalis subsp. lactis DIETARY_SUPPLEMENT

Bifidobacterium animalis subsp. lactis

Eligibility Criteria

• Age: 1 Year - 7 Years
• Sex: all
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Immunodeficiency
• Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to study start)
• Neoplasms
• Severe chronic disorders

Sponsors & Collaborators

• Children's Hospital Zagreb: lead

Study Sites (1)

Djecji vrtic Matija Gubec

Zagreb, 10000, Croatia

Location

Related Publications (1)

• 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.

  PMID: 26031908 DERIVED

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2012
• First Posted: October 8, 2012
• Study Start: January 1, 2013
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: July 26, 2013

Record last verified: 2013-07

Locations

CR (1)