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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN18761855
Enrollment
800
Registered
2008-04-11
Start date
2007-11-20
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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 Lact

Sponsors

Dukat (Croatia)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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

Countries

Croatia

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026