A randomised controlled trial of a probiotic ‘functional food’ in the management of irritable bowel syndrome

BMC Gastroenterology

FD Richard Hobbs¹  Sue Wilson²  Roger Holder²  Deborah McCahon²  Lesley M Roberts² 

[1]Department of Primary Care Health Sciences, Oxford University, 2nd Floor, 23-38 Hythe Bridge Street, Oxford OX1 2ET, UK

[2]Primary Care Clinical Sciences, School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK

关键词: RCT;    IBS;    Functional food;    Probiotic;   

Others  :  858134
DOI  :  10.1186/1471-230X-13-45

 received in 2012-07-12, accepted in 2013-02-22,  发布年份 2013

【 摘 要 】

Background

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.

Methods

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.

Results

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.

Conclusions

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

【 授权许可】

   
2013 Roberts et al.; licensee BioMed Central Ltd.

【 图 表 】

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