Condition category
Infections and Infestations
Date applied
29/01/2008
Date assigned
11/04/2008
Last edited
25/05/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Iva Hojsak

ORCID ID

Contact details

Children's Hospital Zagreb
Klaiceva 16
Zagreb
10000
Croatia
ivahojsak@gmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Probiotics are defined as live microorganisms which confer a beneficial health effect on a human host. The most commonly used probiotics are bacteria of genera Lactobacillus or Bifidobacterium. A probiotic preparation must contain a certain minimum number of Colony-Forming Units (CFU) per dose. Doses used in therapeutic and preventive trials vary (106 to 109 CFUs). There is an increasing number of studies on beneficial effects of probiotics in treatment of acute infectious diarrhoea and prevention of antibiotic associated diarrhoea. However, the role of probiotics in prevention of nosocomial diarrhoea is still controversial.

Probiotics can also be used as preventive measure in gastrointestinal and respiratory tract infection, and although currently randomised controlled trials show a modest effect, future large, prospective studies are necessary.

Hypothesis:
Use of probiotics can effectively reduce the risk of nosocomial gastrointestinal and respiratory infections in acutely ill children.

Ethics approval

Children's Hospital Ethics Committee Zagreb, Klaiceva 16, 10000 Zagreb, Croatia. Date of approval: 22/02/2007 (ref: 01-57/3-1-07)

Study design

Randomised, double-blind, placebo controlled study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Gastrointestinal and respiratory tract infections in children

Intervention

All hospitalised children at the Paediatrics Department whose parents have signed an inform consent will be randomly assigned into one of the two following groups:
Group A: Children will receive Lactobacillus GG at a dose 10^10 CFU per day in fermented milk product during hospitalization
Group B: Children will receive placebo (Post-pasteurized fermented product with similar taste to the active product) daily during hospitalization

Intervention type

Drug

Phase

Not Specified

Drug names

Lactobacillus GG

Primary outcome measures

The following will be monitored during hospitalization and reassessed 7 days after discharge from hospital:
1. Rate of gastrointestinal tract infections including diarrhea (defined as 3 or more loose or watery stools in 24 hours), vomiting
2. Rate of upper respiratory tract infections including rhinitis, pharyngitis, otitis and common cold
3. Rate of lower respiratory tract infections including pneumonia, bronchitis and bronciolitis (diagnosis by physician)
4. Duration of gastrointestinal and respiratory infections
5. Total duration of hospitalisation at the Paediatric Department

Secondary outcome measures

The following will be monitored during hospitalization and reassessed 7 days after discharge from hospital:
1. In patients with gastrointestinal tract infections:
1.1. Duration of symptoms
1.2. Number of stools or vomiting episodes
1.3. Number of infections with determined infective cause: nature of infective etiology
1.4. Duration of hospitalisation at the Paediatric Department

2. In patients with respiratory tract infections:
2.1. Duration of symptoms (cough, fever)
2.2. Severity of infection (mild, moderate, severe)
2.3. Need for antibiotics
2.4. Number of infections with determined infective cause: nature of infective etiology
2.5. Duration of hospitalisation at the Paediatric Department

Overall trial start date

20/11/2007

Overall trial end date

20/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

1. All paediatric patients hospitalised during the period of 6 months at the Department of Paediatrics, Children's Hospital Zagreb
2. Age from 12 months to 18 years

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

800

Participant exclusion criteria

1. Immunodeficiency
2. Infants from neonatal period until 9th month of age
3. Cow's milk allergy (probiotics will be given in fermented cow's milk product)
4. Re-hospitalisation
5. Receiving infant formula containing probiotics and/or prebiotics at the time of enrolment
6. Receiving probiotic and/or prebiotic products prior to enrolment (7 days prior to hospitalisation)
7. Children admitted due to acute gastrointestinal or respiratory infections
8. Neoplasms
9. Chronic disorders

Recruitment start date

20/11/2007

Recruitment end date

20/05/2008

Locations

Countries of recruitment

Croatia

Trial participating centre

Children's Hospital Zagreb
Zagreb
10000
Croatia

Sponsor information

Organisation

Dukat (Croatia)

Sponsor details

Marijana Cavica 9
Zagreb
10000
Croatia

Sponsor type

Industry

Website

http://www.dukat.hr/

Funders

Funder type

Hospital/treatment centre

Funder name

Children's Hospital Zagreb (Croatia)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20403940

Publication citations

  1. Results

    Hojsak I, Abdović S, Szajewska H, Milosević M, Krznarić Z, Kolacek S, Lactobacillus GG in the prevention of nosocomial gastrointestinal and respiratory tract infections., Pediatrics, 2010, 125, 5, e1171-7, doi: 10.1542/peds.2009-2568.

Additional files

Editorial Notes