EFFICACY AND SAFETY OF SMECTA COMBINED WITH ORAL REHYDRATION IN THE TREATMENT OF ACUTE DIARRHEA IN CHILDRE

Not Applicable

Completed

• Conditions: -K591 Functional diarrhoea; Functional diarrhoea; K591

• Registration Number: PER-076-01
• Lead Sponsor: IVERSIDAD PERUANA CAYETANO HEREDIA,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2001-12-28
• Last Update Posted: 2023-09-04

Recruitment & Eligibility

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

Inclusion Criteria

• The authorization statement, before completing any procedure related to the study, must be dated and signed by the accompanying adult and a witness (who could be a member of the medical team).
• Male
• Age between 1 and 36 months (inclusive).
• Acute watery diarrhea defined by a minimum of 3 watery intestinal activities per day for less than 72 hours.
• Need for oral rehydration, according to WHO criteria

Exclusion Criteria

• Current episode of diarrhea previously treated with any antidiarrheal medication.
• Diarrhea caused by medications (eg antibiotic therapy administered the week before entry into the study).
• History of a recent episode (2 weeks) of diarrhea.
• History of persistent diarrhea (> 4 loose stools per day for> 14 days).
• Dense blood in the stools.
• Disease of poor assimilation diagnosed previously.
• Severe dehydration requiring IV therapy, according to WHO criteria.
• Child fed exclusively by breastfeeding.
• Inability to drink.
• Fever> 39 ° C,
• History of illness that requires concomitant treatment.
• Clinical evidence of another disease that requires antibiotic therapy.
• You are currently receiving antibiotic therapy and / or an antidiarrheal agent.
• Weight - height ratio <80%, (average value).
• Child who has been previously included in this study or any other clinical trial completed less than one month ago.

Study & Design

• Study Type: Interventional
• Study Design: Not specified