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含双歧杆菌 Bb-12 的发酵乳治疗儿童便秘:一项随机、双盲、对照试验。

Fermented milk containing Bifidobacterium lactis DN-173 010 in childhood constipation: a randomized, double-blind, controlled trial.

机构信息

Department of Paediatric Gastroenterology and Nutrition, Emma's Children's Hospital Academic Medical Centre, Amsterdam, The Netherlands.

出版信息

Pediatrics. 2011 Jun;127(6):e1392-9. doi: 10.1542/peds.2010-2590. Epub 2011 May 23.

DOI:10.1542/peds.2010-2590
PMID:21606153
Abstract

BACKGROUND

Constipation is a frustrating symptom affecting 3% of children worldwide. A fermented dairy product containing Bifidobacterium lactis strain DN-173 010 was effective in increasing stool frequency in constipated women. Our aim was to assess the effects of this product in constipated children.

METHODS

In this prospective randomized, double-blind, controlled trial, 159 constipated children (defecation frequency < 3 times per week) were randomly allocated to receive either a fermented dairy product that contains B lactis DN-173 010 (n = 79) or a control product (n = 80) twice a day for 3 weeks. The primary endpoint was the change in stool frequency from baseline to after 3 weeks of product consumption. Analyses were by intention to treat.

RESULTS

Eleven children did not return to any follow-up visit (5 in the probiotic group, 6 in the control group) and were therefore excluded from the final analysis. Thus, 74 children in each group were analyzed. The change in stool frequency from baseline to after 3 weeks of product consumption increased in both groups, but the difference was not statistically significant (2.9 ± 3.2 in probiotic group versus 2.6 ± 2.6 in control group, P = .35). There were no serious adverse events.

CONCLUSIONS

In constipated children, the fermented dairy product containing B lactis strain DN-173 010 did increase stool frequency, but this increase was comparable in the control group. There is currently not sufficient evidence to recommend fermented dairy products containing B lactis strain DN-173 010 in this category of patients. Future studies should focus on whether a longer period of probiotic products is more effective in children who have a short history of constipation.

摘要

背景

便秘是一种令人沮丧的症状,影响全球 3%的儿童。一种含有双歧杆菌 lactis 菌株 DN-173 010 的发酵乳制品在增加便秘妇女的粪便频率方面是有效的。我们的目的是评估该产品在便秘儿童中的作用。

方法

在这项前瞻性随机、双盲、对照试验中,159 名便秘儿童(排便频率<每周 3 次)被随机分配接受含有双歧杆菌 lactis 菌株 DN-173 010 的发酵乳制品(n = 79)或对照产品(n = 80),每天两次,持续 3 周。主要终点是从基线到产品使用 3 周后粪便频率的变化。分析按意向治疗进行。

结果

11 名儿童未返回任何随访(益生菌组 5 名,对照组 6 名),因此被排除在最终分析之外。因此,每组有 74 名儿童被分析。两组的粪便频率从基线到产品使用 3 周后均有增加,但差异无统计学意义(益生菌组 2.9 ± 3.2 与对照组 2.6 ± 2.6,P =.35)。没有严重不良事件。

结论

在便秘儿童中,含有双歧杆菌 lactis 菌株 DN-173 010 的发酵乳制品确实增加了粪便频率,但在对照组中增加幅度相当。目前没有足够的证据推荐含有双歧杆菌 lactis 菌株 DN-173 010 的发酵乳制品用于此类患者。未来的研究应集中于在有短期便秘史的儿童中,更长时间使用益生菌产品是否更有效。

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