Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis (GT)

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.

Study Overview

• Status: Completed
• Conditions: Acute Gastroenteritis
• Intervention / Treatment: Device: Gelatin tannate

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 3

Contacts and Locations

Study Locations

• Italy
  • RM
    • Rome, RM, Italy, 00161
      • Department of Pediatrics, Sapienza University of Rome

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: ORS; Controls treated with oral rehydration solution (standard therapy)
Active Comparator: ORS+GT; Group treated with oral rehydration solution plus gelatin tannate	Device: Gelatin tannate; Other Names: Gelenterum

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of stools	difference in the number of stools after treatment initiation in the 2 arms	48 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of diarrhea after treatment initiation in the 2 arms	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	48 hours, 72 hours
Time to normalization of stool consistency	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	48 hours, 72 hours
Number of visits to the emergency room	need for additional visits during the 7 days of treatment in the 2 arms	7 days
Growth	growth parameters in the 2 arms	7 days
Adverse events treatment related	Number of participants with drug-related adverse events in the 2 arms	7 days

Collaborators and Investigators

• Sponsor: University of Roma La Sapienza

Publications and helpful links

General Publications

• Mennini M, Tolone C, Frassanito A, Midulla F, Cucchiara S, Aloi M. Gelatin Tannate for Acute Childhood Gastroenteritis: A Randomized, Single-Blind Controlled Trial. Paediatr Drugs. 2017 Apr;19(2):131-137. doi: 10.1007/s40272-016-0207-z.

Study record dates

Study Major Dates

• Study Start: June 1, 2013
• Primary Completion (Actual): June 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: December 16, 2015
• First Submitted That Met QC Criteria: December 28, 2015
• First Posted (Estimate): December 31, 2015

Study Record Updates

• Last Update Posted (Estimate): December 31, 2015
• Last Update Submitted That Met QC Criteria: December 28, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: 4-2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No