Gelatine tannate in the management of acute gastroenteritis in children: a randomised controlled trial

Abstract

ObjectiveTo assess the efficacy of gelatine tannate (a complex of tannic acid with astringent and anti-inflammatory properties, and a protective gelatine) for the treatment of acute gastroenteritis (AGE) in children.DesignRandomised, double-blind, placebo-controlled trial. Intention-to-treat analysis.SettingTwo paediatric hospitals in Warsaw.ParticipantsChildren younger than 5 years of age with AGE, defined as a change in stool consistency to a 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 (≥3 in 24 hours), lasting for no longer than 5 days.InterventionsSeventy-two children were assigned to receive gelatine tannate (n=36) or placebo (n=36) in addition to standard rehydration therapy. The gelatine tannate was administered at an age-dependent dose (250–500 mg), and both study products were taken four times per day for 5 days.Primary and secondary outcome measuresThe main outcome measure was duration of diarrhoea. Secondary outcomes included the need for intravenous rehydration, need for hospitalisation of outpatients, number of watery stools per day, vomiting, weight gain, adverse events, recurrence of diarrhoea, severity of diarrhoea according to the Vesikari Scale and use of concomitant medications.ResultsSixty-four children (89%) completed the intervention and were included in the analysis. The duration of diarrhoea after randomisation was similar in the gelatine tannate and placebo groups (75.6±27.8 vs 75.5±29.0 hours, respectively, mean difference 0.1 hours, 95% CI −14.1 to 14.3 hours). There was no significant difference between groups in the number of watery stools per day throughout the study period. There were also no differences in any other secondary outcome measures between groups.ConclusionIn children with AGE younger than 5 years of age, gelatine tannate was ineffective as an adjunct to rehydration therapy.Trial registration numberNCT02280759.

Randomized trial to assess the efficacy and safety of xyloglucan for the treatment of acute gastroenteritis in children

“…A recent study with another antidiarrheal product (gelatin tannate) that was similar in design to ours (sample size) (Kołodziej et al, 2018 ) included progress of gastroenteritis of more than 5 days. The authors did not find gelatin tannate to be efficacious, although they did suggest that early administration of the product at onset of symptoms could increase efficacy.…”

“…Mucus is the first barrier that protects the gastrointestinal tract against microorganisms and antigens, and bacterial invasion is related to the opening of narrow junctions. A recent randomized controlled trial (Kołodziej et al, 2018 ) did not report differences with respect to the efficacy of gelatin tannate as treatment in children aged under 5 years.…”

Dispositivos médicos que parecen medicamentos en trastornos de la interacción intestino-cerebro

“…Por otro lado, las diarreas infecciosas inflamatorias son causadas por microbios que secretan citotoxinas, como Clostridioides difficile y Escherichia coli enteroagregativa y enterohemorrágica, o por invasión de los enterocitos, como ocurre con Campylobacter spp. y Entamoeba histolytica, provocando un proceso inflamatorio y destrucción de la barrera intestinal 2,12,13 . En la EII también existe una barrera intestinal débil debido a una respuesta inflamatoria anormal de la mucosa intestinal; esto se ejemplifica en la EII, en la cual se asocia una barrera intestinal débil con aumento de la permeabilidad.…”

“…También evaluaron la composición de la microbiota y observaron un aumento de acinetobacterias en la colitis, y posterior al uso de tanato de gelatina disminuyó la concentración de enterobacterias y enterococos. Además, el tanato de gelatina inhibe el crecimiento de bacterias como Bacteroides fragilis, C. perfringens, E. coli, Enterobacter cloacae, Salmonella typhimurium, H. pylori, Listeria monocytogenes y V. cholerae 12 .…”