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Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis — GT  

Acute Gastroenteritis Clinical Trial

Official title:
Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis: a Prospective, Randomized, Single-blind Controlled Clinical Trial

Clinical Trial Summary

Oral rehydration therapy is the only treatment recommended by the World Health Organization in acute diarrhea in children. The aim of this study was to compare the efficacy and safety of a therapy with gelatin tannate plus oral rehydration versus oral rehydration alone in children with acute gastroenteritis.

This is a single-blind, prospective, randomized and parallel study performed in two Pediatric Services of tertiary referral hospitals. Patients, ages 3 to 36 months with acute gastroenteritis randomized to receive an oral rehydration solution (OR), or an oral rehydration solution plus gelatin tannate (OR+G). The primary outcomes evaluated were: the number of bowel movements after 48 and 72 hours after initiating treatments. Secondary outcomes were: duration of diarrhea (days), stool characteristics and adverse events. Other clinical variables, as weight, fever, vomiting, appetite and the acceptability of the two treatments were also recorded.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02644200
Study type Interventional
Source University of Roma La Sapienza
Contact
Status Completed
Phase Phase 3
Start date June 2013
Completion date June 2014
View Details
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