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Probiotics for the treatment of acute gastroenteritis: a randomised clinical trial with five different preparations

Probiotics for the treatment of acute gastroenteritis: a randomised clinical trial with five different preparations

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN56067537
Enrollment
540
Registered
2007-04-27
Start date
1999-10-01
Completion date
Unknown
Last updated
2020-10-19

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

Conditions

Acute gastroenteritis Digestive System Gastroenteritis

Interventions

All enrolled children were rehydrated orally with 60 mMol Na+ Oral Rehydration Solution (ORS) for 3?6 hours and then re-fed with full strength, lactose-containing formula or cow's milk, depending on a
6 x 10^9 CFU/dose, bid) 3. Saccharomyces boulardii (5 x 10^9 live micro-organisms/dose, bid) 4. Bacillus clausii (10^9 CFU/dose, bid) 5. Mix of Lactobac

Sponsors

Department of Pediatrics, University of Naples Federico II (Italy)
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Apr 7, 2026