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在肠易激综合征患者中具有不良影响的候选益生菌：一项随机对照试验。

A candidate probiotic with unfavourable effects in subjects with irritable bowel syndrome: a randomised controlled trial.

机构信息

Department of Medicine, Innlandet Hospital Trust, Gjøvik, Norway.

出版信息

BMC Gastroenterol. 2010 Feb 10;10:16. doi: 10.1186/1471-230X-10-16.

DOI:10.1186/1471-230X-10-16
PMID:20144246
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC2831047/
Abstract

BACKGROUND

Some probiotics have shown efficacy for patients with irritable bowel syndrome (IBS). Lactobacillus (L.) plantarum MF1298 was found to have the best in vitro probiotic properties of 22 strains of lactobacilli. The aim of this study was to investigate the symptomatic effect of L. plantarum MF1298 in subjects with IBS. Primary outcome was treatment preference and secondary outcomes were number of weeks with satisfactory relief of symptoms and IBS sum score.

METHODS

The design was a randomised double blind placebo-controlled crossover trial. 16 subjects with IBS underwent two three-week periods of daily intake of one capsule of 10(10) CFU L. plantarum MF 1298 or placebo separated by a four-week washout period.

RESULTS

Thirteen participants (81%; 95% CI 57% to 93%; P = 0.012) preferred placebo to L. plantarum MF1298 treatment. The mean (SD) number of weeks with satisfactory relief of symptoms in the periods with L. plantarum MF1298 and placebo were 0.50 (0.89) and 1.44 (1.26), respectively (P = 0.006). IBS sum score was 6.44 (1.81) in the period with L. plantarum MF1298 treatment compared with 5.35 (1.77) in the period with placebo (P = 0.010). With a clinically significant difference in the IBS sum score of 2 in disfavour of active treatment, the number needed to harm was 3.7, 95% CI 2.3 to 10.9.

CONCLUSIONS

This trial shows for the first time an unfavourable effect on symptoms in subjects with IBS after intake of a potential probiotic.

摘要

背景

一些益生菌已被证明对肠易激综合征（IBS）患者有效。研究发现，植物乳杆菌（L.）MF1298 在 22 株乳杆菌中具有最佳的体外益生菌特性。本研究旨在研究植物乳杆菌 MF1298 对 IBS 患者的症状疗效。主要结局是治疗偏好，次要结局是症状缓解满意的周数和 IBS 总评分。

方法

该设计是一项随机双盲安慰剂对照交叉试验。16 名 IBS 患者分别进行为期 3 周的每日摄入 1 粒 10（10）CFU 植物乳杆菌 MF1298 胶囊或安慰剂治疗，间隔 4 周洗脱期。

结果

13 名参与者（81%；95%CI 57%至 93%；P = 0.012）更喜欢安慰剂而非植物乳杆菌 MF1298 治疗。服用植物乳杆菌 MF1298 和安慰剂期间症状缓解满意的周数分别为 0.50（0.89）和 1.44（1.26）（P = 0.006）。服用植物乳杆菌 MF1298 治疗期间 IBS 总评分（1.81）为 6.44，服用安慰剂期间为 5.35（1.77）（P = 0.010）。活性治疗在 IBS 总评分上具有 2 的临床显著差异，不利的数值需要 3.7，95%CI 2.3 至 10.9。

结论

本试验首次显示，摄入潜在益生菌后，IBS 患者的症状出现不利影响。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9278/2831047/54c87d886dde/1471-230X-10-16-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9278/2831047/120355b6ef01/1471-230X-10-16-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9278/2831047/54c87d886dde/1471-230X-10-16-2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9278/2831047/120355b6ef01/1471-230X-10-16-1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9278/2831047/54c87d886dde/1471-230X-10-16-2.jpg

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