A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome

H. J. Kim, Michael Camilleri, S. McKinzie, M. B. Lempke, D. D. Burton, G. M. Thomforde, A. R. Zinsmeister

Research output: Contribution to journalArticle

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Abstract

Aim: To investigate the effects of a probiotic formulation, VSL#3, on gastrointestinal transit and symptoms of patients with Rome II irritable bowel syndrome with predominant diarrhoea. Methods: Twenty-five patients with diarrhoea-predominant irritable bowel syndrome were randomly assigned to receive VSL#3 powder (450 billion lyophilized bacteria/day) or matching placebo twice daily for 8 weeks after a 2-week run-in period. Pre- and post-treatment gastrointestinal transit measurements were performed in all patients. Patients recorded their bowel function and symptoms daily in a diary during the 10-week study, which was powered to detect a 50% change in the primary colonic transit end-point. Results: There were no significant differences in mean gastrointestinal transit measurements, bowel function scores or satisfactory global symptom relief between the two treatment groups, pre- or post-therapy. Differences in abdominal bloating scores between treatments were borderline significant (P = 0.09, analysis of covariance). Further analysis revealed that abdominal bloating was reduced (P = 0,046) with VSL#3 [mean post- minus pre-treatment score, -13.7; 95% confidence interval (CI), - 2.5 to - 24.9], but not with placebo (P = 0.54) (mean post- minus pre-treatment score, -1.7; 95% CI, 7.1 to -10.4). With the exception of changes in abdominal bloating. VSL#3 had no effect on other individual symptoms: abdominal pain, gas and urgency. All patients tolerated VSL#3 well. Conclusion: VSL#3 appears to be promising in the relief of abdominal bloating in patients with diarrhoea-predominant irritable bowel syndrome. This is unrelated to an alteration in gastrointestinal or colonic transit.

Original languageEnglish (US)
Pages (from-to)895-904
Number of pages10
JournalAlimentary Pharmacology and Therapeutics
Volume17
Issue number7
DOIs
StatePublished - Apr 1 2003

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Irritable Bowel Syndrome
Probiotics
Diarrhea
Randomized Controlled Trials
Gastrointestinal Transit
Therapeutics
Placebos
Confidence Intervals
Group Psychotherapy
Powders
Abdominal Pain
Gases
Bacteria

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pharmacology, Toxicology and Pharmaceutics(all)

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A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome. / Kim, H. J.; Camilleri, Michael; McKinzie, S.; Lempke, M. B.; Burton, D. D.; Thomforde, G. M.; Zinsmeister, A. R.

In: Alimentary Pharmacology and Therapeutics, Vol. 17, No. 7, 01.04.2003, p. 895-904.

Research output: Contribution to journalArticle

Kim, H. J. ; Camilleri, Michael ; McKinzie, S. ; Lempke, M. B. ; Burton, D. D. ; Thomforde, G. M. ; Zinsmeister, A. R. / A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome. In: Alimentary Pharmacology and Therapeutics. 2003 ; Vol. 17, No. 7. pp. 895-904.
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