Acute Gastroenteritis Clinical Trial
Official title:
Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis: a Prospective, Randomized, Single-blind Controlled Clinical Trial
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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