Department of Paediatrics, The Medical University of Warsaw, Warszawa, Poland.
BMJ Open. 2018 May 24;8(5):e020205. doi: 10.1136/bmjopen-2017-020205.
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.
Randomised, double-blind, placebo-controlled trial. Intention-to-treat analysis.
Two paediatric hospitals in Warsaw.
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.
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.
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.
Sixty-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.
In children with AGE younger than 5 years of age, gelatine tannate was ineffective as an adjunct to rehydration therapy.
NCT02280759.
评估单宁酸明胶（鞣酸与收敛和抗炎特性的复合物，以及一种保护胶体）治疗儿童急性肠胃炎（AGE）的疗效。
随机、双盲、安慰剂对照试验。意向治疗分析。
华沙的两家儿科医院。
年龄小于 5 岁的 AGE 患儿，定义为粪便稠度改变为稀便或水样便（根据布里斯托尔粪便形态量表或阿姆斯特丹粪便形态量表）和/或排便频率增加（24 小时内≥3 次），持续时间不超过 5 天。
72 名儿童被随机分配接受单宁酸明胶（n=36）或安慰剂（n=36）治疗，同时接受标准补液治疗。单宁酸明胶按年龄依赖性剂量（250-500mg）给药，两种研究药物均每日 4 次，连续服用 5 天。
主要结局指标为腹泻持续时间。次要结局指标包括静脉补液的需求、门诊患者住院的需求、每日水样便的次数、呕吐、体重增加、不良事件、腹泻复发、根据 Vesikari 量表评估的腹泻严重程度以及同时使用的药物。
64 名儿童（89%）完成了干预并纳入分析。随机分组后腹泻持续时间在单宁酸明胶组和安慰剂组相似（分别为 75.6±27.8 小时和 75.5±29.0 小时，平均差异 0.1 小时，95%可信区间 -14.1 至 14.3 小时）。在整个研究期间，两组每日水样便的次数无显著差异。两组间其他次要结局指标也无差异。
在年龄小于 5 岁的 AGE 患儿中，单宁酸明胶作为补液治疗的辅助手段无效。
NCT02280759。
