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Completed

NCT Number: NCT01702766

Bifidobacterium Animalis Subsp. Lactis for Lowering the Risk of Common Infections in Hospitalized Children

Hypothesis: Use of Bifidobacterium animalis subsp. lactis can effectively prevent common nosocomial (gastrointestinal and respiratory) infections. Nosocomial infection will be defined as infections which develop more than 48 hours after admission and they are not present or incubating on admission

This study is a prospective, randomized, double blind, placebo- controlled parallel study in children hospitalized at Children's hospital Zagreb.

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.

The test product is a sachet containing 1 gram of powder. The test product will contain minimum 1 billion CFU (colony forming units) probiotic per serving.

The placebo product is an identical product except for the absence of probiotics.

The study includes an intervention period lasting the length of the hospital stay.

The study product will be consumed daily in the morning together with breakfast.

The consumption of the study products will be taken under the surveillance of the physician.

Data on infections will be diagnosed by a physician and recorded in a CRF. The incidence of infections will be analyzed based on the information recorded in the CRF.

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Key information

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Zagreb

Zagreb, 10000, Croatia

Who can participate

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

Inclusion criteria

  • Children hospitalized at the Department of Paediatrics, Children's Hospital Zagreb
  • Age from 1 year to 18 years
  • Signed informed consent by the parents

Exclusion criteria

  • Immunodeficiency
  • Infants from neonatal period until 1 year of age
  • Re-hospitalisation (readmission in a hospital within one month)
  • Receiving probiotic and /or prebiotic products prior to enrolment (2 weeks prior to hospitalization)
  • Neoplasms
  • Severe chronic diseases
  • Hospitalization shorter than 3 days

Treatment and study plan

Bifidobacterium animalis subsp. lactis

Dietary Supplement

Primary outcomes

  1. Common infections in children

    Number of children with common infections (gastrointestinal and respiratory infections):

    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.

    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. Severity of infection

    Severity of GI infections based on Vesikari scale Severity of respiratory infections according to the physician based on visual analogue scale

Sponsors and collaborators

Lead sponsor

Children's Hospital Zagreb

Other

Registry information

Acronym: PROBIC II

Important dates

Study start
2012
Primary 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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