Gelatin Tannate as Treatment for Acute Childhood Gastroenteritis

NCT02644200 | Completed Phase 3

• 1 other identifier: 4-2015
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Gastroenteritis

Outcome Measures

Primary Outcomes (1)

• Number of stools

  difference in the number of stools after treatment initiation in the 2 arms

  48 hours

Secondary Outcomes (5)

• Duration of diarrhea after treatment initiation in the 2 arms

  48 hours, 72 hours

• Time to normalization of stool consistency

  48 hours, 72 hours

• Number of visits to the emergency room

  7 days

• Growth

  7 days

• Adverse events treatment related

  7 days

Study Arms (2)

ORS

NO INTERVENTION

Controls treated with oral rehydration solution (standard therapy)

ORS+GT

ACTIVE COMPARATOR

Group treated with oral rehydration solution plus gelatin tannate

Device: Gelatin tannate

Interventions

Gelatin tannate DEVICE

Also known as: Gelenterum

ORS+GT

Eligibility Criteria

• Age: 3 Months - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Roma La Sapienza: lead

Study Sites (1)

Department of Pediatrics, Sapienza University of Rome

Rome, RM, 00161, Italy

Location

Related Publications (1)

• 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.

  PMID: 28000174 DERIVED

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: December 16, 2015
• First Posted: December 31, 2015
• Study Start: June 1, 2013
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: December 31, 2015

Record last verified: 2015-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)