Acute gastroenteritis Digestive System Gastroenteritis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Children three to 36 months of age seen in paediatricians' offices because of diarrhoea were eligible for the study. Patients presenting diarrhoea lasting less than 48 hours with informed consent given from parents were included in the study.
Exclusion criteria
Exclusion criteria: 1. Malnutrition as judged by body weight/height ratio 2. Clinical signs of severe dehydration 3. Clinical signs of a coexisting acute systemic illness (meningitis, sepsis, pneumonia) 4. Immunodeficiency 5. Underlying severe chronic diseases 6. Cystic fibrosis 7. Food allergy or other chronic gastrointestinal diseases 8. Use of probiotics in the previous 3 weeks 9. Use of antibiotics or any antidiarrhoeal medication in the previous 3 weeks and during study medication 10. Poor compliance (defined by administration of less than four doses of study medication)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diarrhoea duration defined as the time in hours from the first to the last abnormal (loose or liquid) stools preceding a normal stool output. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Duration of vomiting and fever, defined by the time in days from the first to the last episode of vomiting and/or fever (boby temperature > 37.5°C) 2. Hospitalization investigated as hospital admissions rate | — |
Countries
Italy