title: A randomised controlled trial of a probiotic 'functional food' in the management of irritable bowel syndrome.
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.
authors.affiliation: Primary Care Clinical Sciences, School of Health and Population Sciences, University of Birmingham, Edgbaston, Birmingham B15 2TT, UK.
authors.forename: Lesley M
authors.initials: LM
authors.lastname: Roberts
authors.forename: Deborah
authors.initials: D
authors.lastname: McCahon
authors.forename: Roger
authors.initials: R
authors.lastname: Holder
authors.forename: Sue
authors.initials: S
authors.lastname: Wilson
authors.forename: F D Richard
authors.initials: FD
authors.lastname: Hobbs
mesh_terms: D000328:Adult; D003248:Constipation / Q000453:epidemiology / Q000209:etiology; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D015994:Incidence; D043183:Irritable Bowel Syndrome / Q000150:complications / Q000178:diet therapy*; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000627:therapeutic use*; D011788:Quality of Life; D016896:Treatment Outcome