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17 May 2008
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| [ Print-friendly version ] |
| Lactobacillus GG in prevention of gastrointestinal and respiratory tract infections in healthy children: Randomised, double-blind, placebo-controlled study |
| ISRCTN | ISRCTN16959643 |
| ClinicalTrials.gov identifier | |
| Public title | Lactobacillus GG in prevention of gastrointestinal and respiratory tract infections in healthy 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. Study hypothesis: Use of probiotics can effectively reduce the risk of nosocomial gastrointestinal and respiratory infections in healthy children in kindergarten. |
| 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 | Randomized, double-blind, placebo controlled study |
| Countries of recruitment | Croatia |
| Disease/condition/study domain | Gastrointestinal and respiratory tract infections in children |
| Participants - inclusion criteria | All children attending day care at two kindergartens located in the Zagreb city centre with approximately 300 children, age from 12 months to 7 years. |
| Participants - exclusion criteria |
1. Immunodeficiency
2. Cow's milk allergy (probiotics will be given in fermented cow's milk product) 3. Receiving infant formula containing probiotics and/or prebiotics at the time of enrolment 4. Receiving probiotic and/or prebiotic products prior to enrolment (7 days prior to hospitalization) 5. Neoplasms 6. Chronic disorders |
| Anticipated start date | 20/11/2007 |
| Anticipated end date | 20/02/2008 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 300 |
| Interventions |
All children at kindergarten whose parents have signed an inform consent, would be randomly assigned into one of two following groups:
1.Group A will receive LGG at a dose 10^10 CFU per day in fermented milk product for three months 2.Group B will receive placebo (fermented milk product) daily for three months |
| Primary outcome measure(s) |
The following will be assessed after 3 months of intervention:
1. Rate of gastrointestinal tract infections including diarrhea (defined as 3 or more loose or watery stools in 24 hours) and vomiting 2. Rate of upper respiratory tract infections including rhinitis, pharyngitis, otitis, common cold and sinusitis 3. Rate of lower respiratory tract infections including pneumonia, bronchitis and bronciolitis (diagnosis by physician) 4. Duration of gastrointestinal and respiratory tract infections |
| Secondary outcome measure(s) |
The following will be assessed after 3 months of interventions:
1. In participants 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 2. In participants 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 |
| Sources of funding |
1. Children's Hospital Zagreb (Croatia)
2. Dukat (Croatian milk company) will donate probiotics and fermented milk products |
| Trial website | |
| Publications | |
| Contact name | Dr Iva Hojsak |
| Address |
Children's Hospital Zagreb
Klaiceva 16 |
| City/town | Zagreb |
| Zip/Postcode | 10000 |
| Country | Croatia |
| Sponsor | Dukat (Croatia) |
| Address | M 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 |
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