Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children.

Efficacy of Gelatin Tannate in Treatment Acute Gastroenteritis in Children: A Double Blind Randomized, Placebo- Controlled Trial .

Gelatin tannate possesses astringent, antibacterial, and anti-inflammatory properties. It is increasingly being marketed as an antidiarrheal drug. A randomized, double blind, placebo-control trial was performed to assess the effectiveness of GT in management of children with acute gastroenteritis.

Study Overview

• Status: Completed
• Conditions: Acute Gastroenteritis
• Intervention / Treatment: Drug: Gelatin Tannate; Drug: Placebo

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Phase 1

Contacts and Locations

Study Locations

• Poland
  • Warsaw, Poland, 01-183
    • Department of Paediatrics, The Medical University of Warsaw, Poland

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 3 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• children < 5 years old
• diarrhea (defined as the passage of 3 or more loose or watery stools per day) for > 1 day but < 5 days
• inform consent sign

Exclusion Criteria:

• regularly used antibiotics, probiotics, gelatin tannate, diosmectite, racecadotril within 7 days before admission
• underlying gastrointestinal tract disorder presenting with diarrhea
• breastfeeding >50%
• malnutrition (weight/high <3pc)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Gelatin Tannate; Gelatin Tannate: 4 times 250 mg/daily for 5 days for children under 3. years old or 4 times 500mg/daily for 5 days for children older then 3. years and under 5 years.	Drug: Gelatin Tannate
Placebo Comparator: Placebo; Placebo consists of an identical formulation, except active substance.	Drug: Placebo; Placebo consists of an identical formulation, except active substance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of diarrhea	time till the first normal stool from the onset of diarrhea or normalization number of stools and last those for 48hours	7 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Need of intravenous rehydration due to diarrhea	7 days
Need of hospitalization in outpatients	7 days
Vomiting	How many times for 7days
Weight gain	7 days
Diarrhea recurrence	7 days
Frequency of watery stools	7 days
Adverse effects	7 days
Severity of diarrhea due to modified Vesikari score	7 days

Collaborators and Investigators

• Sponsor: Medical University of Warsaw
• Investigators: Principal Investigator: Hanna Szajewska, Profesor, Medical University of Warsaw

Publications and helpful links

General Publications

• Kolodziej M, Bebenek D, Konarska Z, Szajewska H. Gelatine tannate in the management of acute gastroenteritis in children: a randomised controlled trial. BMJ Open. 2018 May 24;8(5):e020205. doi: 10.1136/bmjopen-2017-020205.
• Michalek D, Kolodziej M, Konarska Z, Szajewska H. Efficacy and safety of gelatine tannate for the treatment of acute gastroenteritis in children: protocol of a randomised controlled trial. BMJ Open. 2016 Feb 19;6(2):e010530. doi: 10.1136/bmjopen-2015-010530. Erratum In: BMJ Open. 2017 Aug 11;7(8):e010530corr1.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): June 10, 2017
• Study Completion (Actual): June 10, 2017

Study Registration Dates

• First Submitted: October 29, 2014
• First Submitted That Met QC Criteria: October 29, 2014
• First Posted (Estimate): October 31, 2014

Study Record Updates

• Last Update Posted (Actual): July 6, 2017
• Last Update Submitted That Met QC Criteria: July 5, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: diarrhea, gelatin tannate, acute gastroenteritis
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: KB56/2014