University of Chicago Section of Pediatric Gastroenterology, Hepatology and Nutrition, Chicago, IL, USA.
J Pediatr Gastroenterol Nutr. 2010 Jul;51(1):24-30. doi: 10.1097/MPG.0b013e3181ca4d95.
: 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.
: 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.
: 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 < 0.05) in the primary endpoint, the subjective assessment of relief of symptoms; as well as in 3 of 4 secondary endpoints: abdominal pain/discomfort (P < 0.05), abdominal bloating/gassiness (P < 0.05), and family assessment of life disruption (P < 0.01). No significant difference was found (P = 0.06) in the stool pattern. No untoward adverse effect was recorded in any of the patients.
: VSL#3 is safe and more effective than placebo in ameliorating symptoms and improving the quality of life in children affected by IBS.
肠易激综合征（IBS）在儿科中较为常见，但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，但在儿科年龄组尚未发表阳性研究。我们旨在研究 VSL#3 在患有 IBS 的儿童和青少年人群中的疗效，进行了一项在 7 个儿科胃肠病学部门进行的随机、双盲、安慰剂对照、交叉研究。
符合入选标准的 4 至 18 岁儿童被纳入研究。患者在 2 周基线期内通过问卷进行评估。然后，他们被随机分为接受 VSL#3 或安慰剂治疗 6 周，每 2 周进行一次对照。最后，在 2 周的“洗脱”期后，每位患者切换到另一组，并再随访 6 周。
共有 59 名儿童完成了研究。尽管安慰剂在一些参数和多达一半的患者中有效，但 VSL#3 在主要终点，即症状缓解的主观评估方面明显优于安慰剂（P < 0.05）；在 4 个次要终点中的 3 个方面也是如此：腹痛/不适（P < 0.05）、腹胀/气胀（P < 0.05）和家庭对生活干扰的评估（P < 0.01）。粪便模式无显著差异（P = 0.06）。在任何患者中均未发现不良的不良反应。
VSL#3 在改善 IBS 患儿的症状和提高生活质量方面安全且比安慰剂更有效。
