Lactobacillus GG in prevention of gastrointestinal and respiratory tract infections in hospitalised children: Randomised, double-blind, placebo controlled study

ISRCTN	ISRCTN18761855
DOI	https://doi.org/10.1186/ISRCTN18761855
Secondary identifying numbers	N/A

Submission date: 29/01/2008
Registration date: 11/04/2008
Last edited: 25/05/2010

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Iva Hojsak
Scientific

Children's Hospital Zagreb
Klaiceva 16
Zagreb
10000
Croatia

Email	ivahojsak@gmail.com

Study information

Study design	Randomised, double-blind, placebo controlled study.
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Prevention
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectives	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(s)	Children's Hospital Ethics Committee Zagreb, Klaiceva 16, 10000 Zagreb, Croatia. Date of approval: 22/02/2007 (ref: 01-57/3-1-07)
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Lactobacillus GG
Primary outcome measure	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 study start date	20/11/2007
Completion date	20/05/2008

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	12 Years
Upper age limit	18 Years
Sex	Both
Target number of participants	800
Key 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
Key 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
Date of first enrolment	20/11/2007
Date of final enrolment	20/05/2008

Locations

Countries of recruitment

Croatia

Study participating centre

Children's Hospital Zagreb

Zagreb
10000
Croatia

Sponsor information

Dukat (Croatia)
Industry

Marijana Cavica 9
Zagreb
10000
Croatia

Website	http://www.dukat.hr/
"ROR"	https://ror.org/05ceh6345

Funders

Funder type

Hospital/treatment centre

Children's Hospital Zagreb (Croatia)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2010		Yes	No