Wojtyniak Katarzyna, Horvath Andrea, Dziechciarz Piotr, Szajewska Hania
Department of Paediatrics, The Medical University of Warsaw, Warsaw, Poland.
J Pediatr. 2017 May;184:101-105.e1. doi: 10.1016/j.jpeds.2017.01.068. Epub 2017 Mar 8.
To assess the effectiveness of Lactobacillus casei rhamnosus Lcr35 (Lcr35) in the management of functional constipation in children.
A randomized, double-blind, placebo-controlled trial was conducted in 94 children aged <5 years with functional constipation according to the Rome III criteria. Children were assigned to receive Lcr35 (8 × 10 colony-forming units, n = 48) or placebo (n = 46), twice daily, for 4 weeks. The primary outcome measure was treatment success, defined as 3 or more spontaneous stools per week, without episodes of fecal soiling, in the last week of the intervention. Analyses were by intention to treat.
Eighty-one (86%) children completed the study. There was no significant difference in treatment success between the placebo and the Lcr35 group (28/40 vs 24/41, respectively; relative risk, 0.6, 95% CI 0.24-1.5, P = .4). There was a significant increase in the frequency of defecation from baseline to week 4 in both the placebo group (median [IQR] 2.0 [1.0, 2.0] to 6.0 [4.0, 9.0], P < .001) and in the Lcr35 group (2.0 [1.0, 2.0] to 4.0 [3.0, 5.0], P < .001), but the defecation frequency in the placebo group was significantly greater than that in the Lcr35 group at weeks 1, 2, 3, and 4.
Lcr35 as a sole treatment was not more effective than placebo in the management of functional constipation in children <5 years. This study adds to current recommendations that do not support the use of probiotics in the treatment of childhood constipation.
ClinicalTrials.gov: NCT01985867.
评估鼠李糖乳杆菌Lcr35（Lcr35）对儿童功能性便秘的治疗效果。
一项随机、双盲、安慰剂对照试验在94名年龄小于5岁、符合罗马III标准的功能性便秘儿童中进行。将儿童分为两组，分别接受Lcr35（8×10菌落形成单位，n = 48）或安慰剂（n = 46）治疗，每日两次，共4周。主要结局指标为治疗成功，定义为干预最后一周每周有3次或更多自主排便且无大便失禁情况。分析采用意向性分析。
81名（86%）儿童完成了研究。安慰剂组和Lcr35组的治疗成功率无显著差异（分别为28/40和24/41；相对危险度，0.6，95%可信区间0.24 - 1.5，P = 0.4）。安慰剂组和Lcr35组从基线到第4周排便频率均显著增加（安慰剂组：中位数[四分位间距]从2.0[1.0, 2.0]增至6.0[4.0, 9.0]，P < 0.001；Lcr35组：从2.0[1.0, 2.0]增至4.0[3.0, 5.0]，P < 0.001），但在第1、2、3和4周时，安慰剂组的排便频率显著高于Lcr35组。
在治疗5岁以下儿童功能性便秘方面，单独使用Lcr35并不比安慰剂更有效。本研究进一步支持了目前不推荐使用益生菌治疗儿童便秘的建议。
ClinicalTrials.gov：NCT01985867。
