Racecadotril For The Treatment Of Acute Watery Diarrhoea In Children. A Randomised Double Blinded Placebo Controlled Trial

Not Applicable

Recruiting

• Conditions: Digestive System; Paediatrics; Acute Gastroenteritis

• Registration Number: PACTR201403000694398
• Lead Sponsor: Aga Khan University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-11-02
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Children 3mo ¿ 60mo
Acute gastroenteritis as defined by WHO (the passage of unusually loose or watery stools, usually at least three times in a 24 hour period)
requiring admission for severe gastroenteritis (as evidenced by a vesicari score of >11)
parental consent obtained

Exclusion Criteria

Scoring 3 on the vesicari score for Maximum Number Vomiting Episodes per Day
Clinical diagnosis of dysentery
Requiring / having been prescribed antibiotics and/or probiotics or any other anti-diarrhoeal medication for the disease (except zinc)
known diagnosis of liver and renal failure

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
severity of the diarrhoeal illness, measured by the number of stools in the first 48 hours after introduction of the drug and the consistency of stools at 48 hours

Secondary Outcome Measures

Name	Time	Method
the duration of inpatient stay ;number of adverse events associated with racecadotril