|
Welcome
|
|
17 May 2008
|
|
|
| home | my details | ISRCTN Register | mRCT | UKCTG | links | information | press |
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
|
||||
| [ Print-friendly version ] |
| Lactobacillus GG in prevention of gastrointestinal and respiratory tract infections in hospitalised children: Randomised, double-blind, placebo controlled study |
| ISRCTN | ISRCTN18761855 |
| ClinicalTrials.gov identifier | |
| Public title | Lactobacillus GG in prevention of gastrointestinal and respiratory tract infections in hospitalised children: Randomised, double-blind, placebo controlled study |
| Scientific title | |
| Acronym | N/A |
| Serial number at source | N/A |
| 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. |
| Countries of recruitment | Croatia |
| Disease/condition/study domain | Gastrointestinal and respiratory tract infections in children |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 20/11/2007 |
| Anticipated end date | 20/05/2008 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 800 |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | Children's Hospital Zagreb (Croatia) |
| Trial website | |
| Publications | |
| Contact name | Dr Iva Hojsak |
| Address |
Children's Hospital Zagreb
Klaiceva 16 |
| City/town | Zagreb |
| Zip/Postcode | 10000 |
| Country | Croatia |
| ivahojsak@gmail.com | |
| Sponsor | Dukat (Croatia) |
| Address | Marijana Cavica 9 |
| City/town | Zagreb |
| Zip/Postcode | 10000 |
| Country | Croatia |
| Sponsor website: | http://www.dukat.hr/ |
| Date applied | 29/01/2008 |
| Last edited | 11/04/2008 |
| Date ISRCTN assigned | 11/04/2008 |
 |
|||
|
|
|
| © ISRCTN | |
|
|
|
|