Primary Care Clinical Sciences, School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
BMC Gastroenterol. 2013 Mar 7;13:45. doi: 10.1186/1471-230X-13-45.
Irritable Bowel Syndrome (IBS) is a common condition characterised by pain, distension and altered bowel habit. Evidence suggests functional foods containing probiotics improve gastrointestinal transit, however, data are limited by short follow-up periods and evaluation in selected populations.
A multi-centre, randomized, double blind, controlled trial to evaluate the effect of a probiotic vs non-probiotic dairy product on symptoms in IBS with a constipation element (IBS-Constipation or IBS-Mixed profile). Set in 13 general practices within central England. Individuals meeting the ROME III criteria for IBS, aged 18-65 completed a pre-study diary. Eligible individuals were randomized to consume dairy 'yoghurt' products which either did or did not contain active probiotics twice daily and to complete a daily diary. Primary outcome was subjective global assessment of symptom relief at week 4. Other outcomes comprised, IBS symptom scores, pain, bloating and flatulence levels, stool frequency, stool consistency, ease of bowel movement and quality of life.
179 were randomized (91 active, 88 placebo). 76 (43 active, 33 placebo) completed the study. No significant between group differences existed at 4 weeks (57% active vs 53% placebo, reported adequate relief (p = 0.71)). By week 8, 46% active vs 68% placebo reported adequate relief (p = 0.03). This was sustained at week 12.
Significant improvements were reported for most outcomes in all trial participants but improvement did not differ by group. This trial does not provide evidence for effectiveness of a probiotic in IBS, in variance with a body of published literature and review conclusions. Differential drop out may however cloud interpretation of data. UK TRIAL REGISTRATION: ISRCTN78863629.
肠易激综合征（IBS）是一种常见的疾病，其特征为疼痛、腹胀和排便习惯改变。有证据表明，含有益生菌的功能性食品可改善胃肠道转运，但由于随访时间短且在特定人群中进行评估，数据有限。
本研究为多中心、随机、双盲、对照试验，旨在评估益生菌与非益生菌乳制品对伴有便秘成分的肠易激综合征（IBS-便秘或 IBS-混合型）患者症状的影响。试验在英格兰中部的 13 家普通诊所进行。符合罗马 III 标准的 IBS 患者完成了研究前日记。符合条件的患者被随机分配至每日两次食用含有或不含有活性益生菌的乳制品酸奶，并完成每日日记。主要结局为第 4 周时症状缓解的主观总体评估。其他结局包括 IBS 症状评分、疼痛、腹胀和呃逆程度、排便频率、粪便稠度、排便通畅程度和生活质量。
共 179 人随机分组（91 人服用活性药物，88 人服用安慰剂），76 人（43 人服用活性药物，33 人服用安慰剂）完成了研究。4 周时，两组间无显著差异（57%的活性药物组和 53%的安慰剂组报告症状缓解充分（p = 0.71））。第 8 周时，46%的活性药物组和 68%的安慰剂组报告症状缓解充分（p = 0.03），第 12 周时这一结果仍持续。
所有试验参与者的大多数结局均报告有显著改善，但组间改善无差异。本试验并未提供益生菌治疗 IBS 有效的证据，与已发表的文献和综述结论不一致。但差异较大的脱落率可能会影响数据的解释。英国临床试验注册：ISRCTN78863629。
