title: Efficacy and safety of gelatine tannate for the treatment of acute gastroenteritis in children: protocol of a randomised controlled trial.
abstract: Worldwide, acute gastroenteritis in children, usually caused by viruses, leads to considerable morbidity and mortality. The treatment is aimed at preventing and treating dehydration, promoting weight gain after rehydration, and reducing the duration and severity of diarrhoea. Effective and inexpensive interventions that could add to the effect of oral rehydration therapy are of interest. Recently, in many European countries, gelatine tannate is being widely marketed for treating acute gastroenteritis. Gelatine tannate is a complex of tannic acid, which possesses astringent and anti-inflammatory properties, and a protective gelatine. Currently, there is no evidence to support the use of gelatine tannate for treating acute gastroenteritis in children and only scant evidence to support the use of gelatine tannate in adults. We aim to assess the efficacy of gelatine tannate for the treatment of acute gastroenteritis in children.
  
  
  
  This will be a blind, placebo-controlled, randomised trial. Children younger than 5 years of age with acute gastroenteritis defined as a change in stool consistency to loose or liquid form (according to the Bristol Stool Form scale or Amsterdam Stool Form scale) and/or an increase in the frequency of evacuations (typically ≥ 3 in 24 h), lasting for no longer than 5 days, will be recruited. A total of 72 children will be randomised to receive either gelatine tannate (children younger than 3 years of age will receive 250 mg, 4 times/day, and those older than 3 years of age will receive 500 mg, 4 times/day) or matching placebo for 5 days. The primary outcome measure is the duration of diarrhoea.
  
  
  
  The Bioethics Committee approved the study protocol. The findings of this trial will be submitted to a peer-reviewed paediatric journal. Abstracts will be submitted to relevant national and international conferences.
  
  
  
  NCT02280759; Pre-results.
authors.affiliation: Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
authors.forename: Dorota
authors.initials: D
authors.lastname: Michałek
authors.affiliation: Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
authors.forename: Maciej
authors.initials: M
authors.lastname: Kołodziej
authors.affiliation: Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
authors.forename: Zofia
authors.initials: Z
authors.lastname: Konarska
authors.affiliation: Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
authors.forename: Hania
authors.initials: H
authors.lastname: Szajewska
mesh_terms: D000208:Acute Disease; D002675:Child, Preschool; D005060:Europe; D005759:Gastroenteritis / Q000188:drug therapy*; D005780:Gelatin / Q000627:therapeutic use*; D006801:Humans; D012107:Research Design; D016037:Single-Blind Method; D013634:Tannins / Q000627:therapeutic use*; D016896:Treatment Outcome
chemical_list: D013634:Tannins; C586501:tannate gelatin; D005780:Gelatin
keywords: RCT; antidiarrheal drugs; children; diarrhea