1 Eskisehir Osmangazi University Faculty of Medicine, Department of Pediatrics, Pediatric Intensive Care and Infectious Disease Unit, 26480 Eskisehir, Turkey.
Benef Microbes. 2015;6(4):415-21. doi: 10.3920/BM2014.0086. Epub 2015 Feb 12.
Evidence from the literature has shown that Saccharomyces boulardii provides a clinically significant benefit in the treatment of acute infectious diarrhoea in children. In this multicentre, randomised, prospective, controlled, single blind clinical trial performed in children with acute watery diarrhoea, we aimed to evaluate the impact of S. boulardii CNCM I-745 in hospitalised children, in children requiring emergency care unit (ECU) stay and in outpatient settings. The primary endpoint was the duration of diarrhoea (in hours). Secondary outcome measures were duration of hospitalisation and diarrhoea at the 3(rd) day of intervention. In the whole study group (363 children), the duration of diarrhoea was approximately 24 h shorter in the S. boulardii group (75.4±33.1 vs 99.8±32.5 h, P<0.001). The effect of S. boulardii (diarrhoea-free children) was observed starting at 48 h. After 72 h, only 27.3% of the children receiving probiotic still had watery diarrhoea, in contrast to 48.5% in the control group (P<0.001). The duration of diarrhoea was significantly reduced in the probiotic group in hospital, ECU and outpatient settings (P<0.001, P<0.01 and P<0.001, respectively). The percentage of diarrhoea-free children was significantly larger after 48 and 72 h in all settings. The mean length of hospital stay was shorter with more than 36 h difference in the S. boulardii group (4.60±1.72 vs 6.12±1.71 days, P<0.001). The mean length of ECU stay was shorter with more than 19 h difference in the probiotic group (1.20±0.4 vs 2.0±0.3 days, P<0.001). No adverse effects related to the probiotic were noted. Because treatment can shorten the duration of diarrhoea and reduce the length of ECU and hospital stay, there is likely a social and economic benefit of S. boulardii CNCM I-745 in adjunction to oral rehydration solution in acute infectious gastroenteritis in children.
文献证据表明，布拉氏酵母菌在治疗儿童急性感染性腹泻方面具有显著的临床获益。在这项多中心、随机、前瞻性、对照、单盲临床试验中，我们旨在评估布拉氏酵母菌 CNCM I-745 对急性水样腹泻住院儿童、需要急诊留观（ECU）的儿童和门诊儿童的影响。主要终点是腹泻持续时间（小时）。次要终点是住院时间和干预第 3 天的腹泻情况。在整个研究组（363 例儿童）中，布拉氏酵母菌组的腹泻持续时间平均缩短约 24 小时（75.4±33.1 小时比 99.8±32.5 小时，P<0.001）。布拉氏酵母菌（无腹泻儿童）的作用在 48 小时开始显现。72 小时后，接受益生菌治疗的儿童中仅有 27.3%仍有水样腹泻，而对照组为 48.5%（P<0.001）。在住院、ECU 和门诊环境中，益生菌组的腹泻持续时间均显著缩短（P<0.001、P<0.01 和 P<0.001）。在所有环境中，48 和 72 小时后，无腹泻儿童的比例显著更大。布拉氏酵母菌组的平均住院时间缩短超过 36 小时（4.60±1.72 天比 6.12±1.71 天，P<0.001）。益生菌组的平均 ECU 停留时间缩短超过 19 小时（1.20±0.4 天比 2.0±0.3 天，P<0.001）。未观察到与益生菌相关的不良反应。由于治疗可以缩短腹泻持续时间，减少 ECU 和住院时间，因此布拉氏酵母菌 CNCM I-745 联合口服补液盐治疗儿童急性感染性胃肠炎可能具有社会和经济效益。
