NCT02644200

Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: University of Roma La Sapienza · Academic / Other
• Sex: All
• Age: 3 Months – 5 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Gastroenteritis

Interventions

Type	Name	Description
DEVICE	Gelatin tannate

Timeline

• Start date: 2013-06-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2015-12-31
• Last updated: 2015-12-31

Locations

1 site across 1 country: Italy