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

Lesley M Roberts, Deborah McCahon, Roger Holder, Sue Wilson, F D Richard Hobbs

Research output: Contribution to journalArticle (Academic Journal)peer-review

56 Citations (Scopus)

Abstract

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.

Original languageEnglish
Pages (from-to)45
JournalBMC Gastroenterology
Volume13
DOIs
Publication statusPublished - 7 Mar 2013

Keywords

  • Adult
  • Constipation
  • Double-Blind Method
  • Female
  • Humans
  • Incidence
  • Irritable Bowel Syndrome
  • Male
  • Middle Aged
  • Probiotics
  • Quality of Life
  • Treatment Outcome
  • Journal Article
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

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