title: Randomized clinical trial on the effect of a multispecies probiotic on visceroperception in hypersensitive IBS patients.
abstract: BACKGROUND
  Irritable bowel syndrome (IBS) is characterized by heterogeneous pathophysiology and low response to treatment. Up to 60% of IBS patients suffers from visceral hypersensitivity, which is associated with symptom severity and underlying pathophysiological mechanisms. Recently, positive effects of probiotics in IBS have been reported, but overall the response was modest. We performed a study in IBS patients, characterized by visceral hypersensitivity measured with the rectal barostat, aiming to assess the effect of 6 weeks of multispecies probiotic mix on visceral pain perception.
  
  
  METHODS
  We conducted a randomized, placebo-controlled, double-blind trial in forty Rome III IBS patients with visceral hypersensitivity. Prior to intake, patients kept a 2-week symptom diary and underwent a rectal barostat measurement. When hypersensitivity was confirmed, participation was allowed and patients received a multispecies probiotic with in vitro proven potential beneficial effects on mechanisms contributing to visceral hypersensitivity (six different probiotic strains; 10(9)  cfu/g), or a placebo product of one sachet (5 g) per day for 6 weeks. At the end of the intervention period, visceroperception and symptoms were reassessed.
  
  
  RESULTS
  Thirty-five patients completed the trial. The percentage of patients with visceral hypersensitivity decreased significantly in the probiotic and placebo group (76.5% and 71.4%, respectively; N.S. between groups). Improvement in pain scores and mean symptom score did not differ between the probiotic and placebo group.
  
  
  CONCLUSIONS
  In this placebo-controlled trial in IBS patients with visceral hypersensitivity, no significant effect of a multispecies probiotic on viscerperception was observed. The study has been registered in the US National Library of Medicine (http://www.clinicaltrials.gov, NCT00702026).
authors.affiliation: Division Gastroenterology and Hepatology, Department of Internal Medicine, Maastricht University Medical Center+, Maastricht, The Netherlands.
authors.forename: S
authors.initials: S
authors.lastname: Ludidi
authors.forename: D M
authors.initials: DM
authors.lastname: Jonkers
authors.forename: C J
authors.initials: CJ
authors.lastname: Koning
authors.forename: J W
authors.initials: JW
authors.lastname: Kruimel
authors.forename: L
authors.initials: L
authors.lastname: Mulder
authors.forename: I B
authors.initials: IB
authors.lastname: van der Vaart
authors.forename: J M
authors.initials: JM
authors.lastname: Conchillo
authors.forename: A A M
authors.initials: AA
authors.lastname: Masclee
mesh_terms: D000328:Adult; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D006930:Hyperalgesia / Q000188:drug therapy* / Q000503:physiopathology; D043183:Irritable Bowel Syndrome / Q000188:drug therapy* / Q000503:physiopathology; D008297:Male; D008875:Middle Aged; D019936:Probiotics / Q000627:therapeutic use*; D016896:Treatment Outcome; D059265:Visceral Pain / Q000188:drug therapy* / Q000503:physiopathology
keywords: barostat; irritable bowel syndrome; probiotics; symptoms; visceral hypersensitivity