Effectiveness of Smecta in the Treatment of Acute Diarrhoea in Childre

Not Applicable

• Conditions: -R195 Other faecal abnormalities; Other faecal abnormalities; R195

• Registration Number: PER-018-06
• Lead Sponsor: IPSEN PHARMA,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2006-05-29
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1. Informed written consent signed and signed before completing any procedure related to the study, granted by a parent or legal guardian accompanying the patient.
2. Male.
3. Age: from 1 month to 36 months.
4. Acute watery diarrhea.
5. Duration of acute watery diarrhea less than 72 hours, with at least 1 liquid deposition in the last 12 hours.
6. Signs of dehydration that require oral rehydration, according to current WHO guidelines.
7. Acceptance of hospitalization for 72 hours.

Exclusion Criteria

1. Acute dehydration requiring IV treatment.
2. Evident presence of blood in the stool.
3. Fever> 39 ° C.
4. History of recent episodes (2 weeks) of diarrhea.
5. Previous history of episodes of persistent diarrhea.
6. Malabsorption syndrome previously diagnosed.
7. History of organic gastrointestinal disease.
8. Current treatment with antidiarrheal medication in therapeutic doses and for at least 48 hours.
9. Drug-induced diarrhea.
10. Clinical evidence of another disease that requires antibiotic treatment or any other treatment that could interfere with the evaluation of the study medication.
11. Children exclusively breastfed.
12. Inability to drink.
13. Weight / height ratio <80%.
14. Children previously included in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified