Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis

Phase 3

Completed

• Conditions: Acute Gastroenteritis
• Interventions: Device: Gelatin tannate

• Registration Number: NCT02644200
• Lead Sponsor: University of Roma La Sapienza

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-12
• Study First Submitted: 2015-12-16
• Study First Submitted QC: 2015-12-28
• Last Update Submitted: 2015-12-28
• Study First Posted: 2015-12-31
• Last Update Posted: 2015-12-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Children of both sex, aged 3 months to 5 years of age
• Clinical diagnosis of acute gastroenteritis, as defined by having at least 3 loose stools within the previous 24 hours and/or a change in stool consistency to loose or liquid according to Bristol Stool Form Scale for Children (m-BSFS-C) lasting for no longer than 3 days.

Exclusion Criteria

• patients with gastroenteritis lasting more than 5 days
• patients with chronic gastrointestinal conditions
• patients receiving other antidiarrheal drugs within 2 weeks prior to enrollment (i.e. antibiotics, probiotics, salicylates, loperamide, racecadotril, disomectite)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ORS+GT	Gelatin tannate	Group treated with oral rehydration solution plus gelatin tannate

Primary Outcome Measures

Name	Time	Method
Number of stools	48 hours	difference in the number of stools after treatment initiation in the 2 arms

Secondary Outcome Measures

Name	Time	Method
Growth	7 days	growth parameters in the 2 arms
Time to normalization of stool consistency	48 hours, 72 hours	Stool consistency was evaluated on a modified Bristol Stool Form Scale for Children (m-BSFS-C) and defined as: 1: separate hard lumps, like nuts; 2: Sausage-shaped but lumpy; 3: like a sausage or snake, smooth and soft; 4: fluffy pieces with ragged edges, a mushy stool; 5: watery, no solid pieces
Adverse events treatment related	7 days	Number of participants with drug-related adverse events in the 2 arms
Number of visits to the emergency room	7 days	need for additional visits during the 7 days of treatment in the 2 arms
Duration of diarrhea after treatment initiation in the 2 arms	48 hours, 72 hours	The duration of diarrhea was defined as the time in hours from enrolment to the last abnormal (loose or liquid) stool. Last abnormal stool was defined when the child passed to normal stool or no stool for next 24 hours

Trial Locations

Locations (1)

Department of Pediatrics, Sapienza University of Rome; 🇮🇹 Rome, RM, Italy