Gelatine tannate in the management of acute gastroenteritis in children: a randomised controlled trial
Abstract
Objective To 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. Design Randomised, double-blind, placebo-controlled trial. Intention-to-treat analysis. Setting Two paediatric hospitals in Warsaw. Participants Children 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. Interventions Seventy-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 measures The 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. Results Sixty-four children (89%) completed the intervention and were included in the analysis. The duration of diarrhoea after randomisation was similar in the gelatine…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 36 participants or records.
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