VSL#3 Improves Symptoms in Children With Irritable Bowel Syndrome: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Crossover Study
VSL#3 Improves Symptoms in Children With Irritable Bowel Syndrome: A Multicenter, Randomized, Placebo-Controlled, Double-Blind, Crossover Study
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DOI：
10.1097/mpg.0b013e3181ca4d95
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发表时间：
2010-07-01
影响因子：
2.9
通讯作者：
Setty, Mala
中科院分区：
文献类型：
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作者：
Guandalini, Stefano;Magazzu, Giuseppe;Setty, Mala
背景与目的：肠易激综合征（IBS）是儿科常见病，目前尚无安全有效的治疗方法。益生菌在成人研究中显示出一些有希望的结果，但尚未发表关于儿童年龄的积极研究。我们的目的是在7个儿科胃肠病部门进行的一项随机、双盲、安慰剂对照、交叉研究中，调查VSLI #3在受IBS影响的儿童和青少年人群中的疗效。在2周的基线期内，通过问卷调查对患者进行评估。然后将其随机接受VSLI #3或安慰剂治疗6周，对照组每2周一次。在结束时，经过2周的“清洗”期，每个病人被切换到另一组，并随后为另外6 weeks.Results：共有59名儿童完成了研究。尽管安慰剂在某些参数和多达一半的患者中有效，但VSLI #3显著上级安慰剂（P
Background and Objectives: Irritable bowel syndrome (IBS) is a common problem in pediatrics, for which no safe and effective treatment is available. Probiotics have shown some promising results in adult studies, but no positive study has been published on pediatric age. We aimed at investigating the efficacy of VSL#3 in a population of children and teenagers affected by IBS, in a randomized, double-blind, placebo-controlled, crossover study conducted in 7 pediatric gastroenterology divisions.Patients and Methods: Children 4 to 18 years of age, meeting eligibility criteria, were enrolled. The patients were assessed by a questionnaire for a 2-week baseline period. They were then randomized to receive either VSL#3 or a placebo for 6 weeks, with controls every 2 weeks. At the end, after a "wash-out'' period of 2 weeks, each patient was switched to the other group and followed for a further 6 weeks.Results: A total of 59 children completed the study. Although placebo was effective in some of the parameters and in as many as half of the patients, VSL#3 was significantly superior to it (P