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

Completed

Conditions: Gastrointestinal and respiratory tract infections in children
Infections and Infestations
Nosocomial condition

Registration Number: ISRCTN18761855

Lead Sponsor: Dukat (Croatia)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: All

Target Recruitment: 800

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The following will be monitored during hospitalization and reassessed 7 days after discharge from hospital: <br>1. Rate of gastrointestinal tract infections including diarrhea (defined as 3 or more loose or watery stools in 24 hours), vomiting <br>2. Rate of upper respiratory tract infections including rhinitis, pharyngitis, otitis and common cold <br>3. Rate of lower respiratory tract infections including pneumonia, bronchitis and bronciolitis (diagnosis by physician) <br>4. Duration of gastrointestinal and respiratory infections <br>5. Total duration of hospitalisation at the Paediatric Department

Secondary Outcome Measures

Name	Time	Method
The following will be monitored during hospitalization and reassessed 7 days after discharge from hospital: <br>1. In patients 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>1.4. Duration of hospitalisation at the Paediatric Department <br><br>2. In patients 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 <br>2.5. Duration of hospitalisation at the Paediatric Department