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

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.

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  • Authors+Show Affiliations

    ,

    Clinical Enteric Neuroscience Translational & Epidemiological Research Program, Mayo Clinic and Mayo Foundation, Rochester, MN 55905, USA.

    , , , , ,

    Source

    Alimentary pharmacology & therapeutics 17:7 2003 Apr 01 pg 895-904

    MeSH

    Adolescent
    Adult
    Aged
    Colonic Diseases, Functional
    Diarrhea
    Double-Blind Method
    Female
    Gastrointestinal Transit
    Humans
    Male
    Middle Aged
    Patient Compliance
    Probiotics
    Treatment Outcome

    Pub Type(s)

    Clinical Trial
    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't
    Research Support, U.S. Gov't, P.H.S.

    Language

    eng

    PubMed ID

    12656692

    Citation

    Kim, H J., et al. "A Randomized Controlled Trial of a Probiotic, VSL#3, On Gut Transit and Symptoms in Diarrhoea-predominant Irritable Bowel Syndrome." Alimentary Pharmacology & Therapeutics, vol. 17, no. 7, 2003, pp. 895-904.
    Kim HJ, Camilleri M, McKinzie S, et al. A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome. Aliment Pharmacol Ther. 2003;17(7):895-904.
    Kim, H. J., Camilleri, M., McKinzie, S., Lempke, M. B., Burton, D. D., Thomforde, G. M., & Zinsmeister, A. R. (2003). A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome. Alimentary Pharmacology & Therapeutics, 17(7), pp. 895-904.
    Kim HJ, et al. A Randomized Controlled Trial of a Probiotic, VSL#3, On Gut Transit and Symptoms in Diarrhoea-predominant Irritable Bowel Syndrome. Aliment Pharmacol Ther. 2003 Apr 1;17(7):895-904. PubMed PMID: 12656692.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - A randomized controlled trial of a probiotic, VSL#3, on gut transit and symptoms in diarrhoea-predominant irritable bowel syndrome. AU - Kim,H J, AU - Camilleri,M, AU - McKinzie,S, AU - Lempke,M B, AU - Burton,D D, AU - Thomforde,G M, AU - Zinsmeister,A R, PY - 2003/3/27/pubmed PY - 2003/6/24/medline PY - 2003/3/27/entrez SP - 895 EP - 904 JF - Alimentary pharmacology & therapeutics JO - Aliment. Pharmacol. Ther. VL - 17 IS - 7 N2 - 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. SN - 0269-2813 UR - https://www.unboundmedicine.com/medline/citation/12656692/A_randomized_controlled_trial_of_a_probiotic_VSL L2 - https://onlinelibrary.wiley.com/resolve/openurl?genre=article&sid=nlm:pubmed&issn=0269-2813&date=2003&volume=17&issue=7&spage=895 DB - PRIME DP - Unbound Medicine ER -