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NCT Number: NCT01702753

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

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).

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Key information

Age range

1 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Djecji vrtic Matija Gubec

Zagreb, 10000, Croatia

Who can participate

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bifidobacterium animalis subsp. lactis

Dietary Supplement

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

    Duration of symptoms in days

Other outcomes

  1. Infections with determined infective cause

    Number of gastrointestinal and erspiratory tract infections with proven infective cause (if determined)

Sponsors and collaborators

Lead sponsor

Children's Hospital Zagreb

Other

Registry information

Official study title

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

Acronym: PROBBIC

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Oct 8, 2012
Registry last updated
Jul 26, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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