actobacillus GG in prevention of gastrointestinal and respiratory tract infections in healthy children: Randomised, double-blind, placebo-controlled study
Completed
- Conditions
- Gastrointestinal and respiratory tract infections in childrenInfections and InfestationsNosocomial condition
- Registration Number
- ISRCTN16959643
- Lead Sponsor
- Dukat (Croatia)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 300
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.
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The following will be assessed after 3 months of intervention:<br>1. Rate of gastrointestinal tract infections including diarrhea (defined as 3 or more loose or watery stools in 24 hours) and vomiting<br>2. Rate of upper respiratory tract infections including rhinitis, pharyngitis, otitis, common cold and sinusitis<br>3. Rate of lower respiratory tract infections including pneumonia, bronchitis and bronciolitis (diagnosis by physician)<br>4. Duration of gastrointestinal and respiratory tract infections
- Secondary Outcome Measures
Name Time Method The following will be assessed after 3 months of interventions: <br>1. In participants with gastrointestinal tract infections: <br>1.1. Duration of symptoms <br>1.2. Number of stools or vomiting episodes <br>1.3. Number of infections with determined infective cause: Nature of infective etiology <br><br>2. In participants with respiratory tract infections: <br>2.1. Duration of symptoms (cough, fever) <br>2.2. Severity of infection (mild, moderate, severe) <br>2.3. Need for antibiotics <br>2.4. Number of infections with determined infective cause: Nature of infective etiology