Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis

Acute Gastroenteritis Clinical Trial

— GT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02644200
• Other study ID #: 4-2015
• Status: Completed
• Phase: Phase 3
• First received: December 16, 2015
• Last updated: December 28, 2015
• Start date: June 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2015
• Source: University of Roma La Sapienza
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months to 5 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis

Intervention

Device:
• Gelatin tannate

Locations

Country	Name	City	State
Italy	Department of Pediatrics, Sapienza University of Rome	Rome	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Roma La Sapienza

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of stools	difference in the number of stools after treatment initiation in the 2 arms	48 hours	No
Secondary	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	No
Secondary	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	No
Secondary	Number of visits to the emergency room	need for additional visits during the 7 days of treatment in the 2 arms	7 days	No
Secondary	Growth	growth parameters in the 2 arms	7 days	No
Secondary	Adverse events treatment related	Number of participants with drug-related adverse events in the 2 arms	7 days	Yes