Lactobacillus GG in prevention of gastrointestinal and respiratory tract infections in healthy children: Randomised, double-blind, placebo-controlled study
| ISRCTN | ISRCTN16959643 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16959643 |
| Secondary identifying numbers | N/A |
- Submission date
- 29/01/2008
- Registration date
- 11/04/2008
- Last edited
- 02/12/2010
- 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
Not provided at time of registration
Contact information
Dr Iva Hojsak
Scientific
Scientific
Children's Hospital Zagreb
Klaiceva 16
Zagreb
10000
Croatia
Study information
| Study design | Randomized, 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 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(s) | Children's Hospital Ethics Committee Zagreb, Klaiceva 16, 10000 Zagreb, Croatia. Date of approval: 22/02/2007 (ref: 01-57/3-1-07) |
| Condition | Gastrointestinal and respiratory tract infections in children |
| Intervention | 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 |
| Intervention type | Other |
| Primary outcome measure | 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 measures | 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 |
| Overall study start date | 20/11/2007 |
| Overall study end date | 20/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 12 Months |
| Upper age limit | 7 Years |
| Sex | Both |
| Target number of participants | 300 |
| Participant 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. |
| Participant 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 |
| Recruitment start date | 20/11/2007 |
| Recruitment end date | 20/02/2008 |
Locations
Countries of recruitment
- Croatia
Study participating centre
Children's Hospital Zagreb
Zagreb
10000
Croatia
10000
Croatia
Sponsor information
Dukat (Croatia)
Industry
Industry
M 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
Dukat (Croatian milk company) will donate probiotics and fermented milk products
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 | 01/06/2010 | Yes | No |
