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Clinical trial assessing VSL#3 for the treatment of anterior resection syndrome

Authors

  • Jacqueline H. Stephens,

    Corresponding author
    1. Discipline of Surgery, The University of Adelaide, The Queen Elizabeth Hospital
    2. Division of Surgery, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia
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  • Peter J. Hewett

    1. Discipline of Surgery, The University of Adelaide, The Queen Elizabeth Hospital
    2. Division of Surgery, The Queen Elizabeth Hospital, Woodville South, South Australia, Australia
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  • J. H. Stephens MPH; P. J. Hewett FRACS.

  • Source of support: The study product was provided by Orphan Australia Pty Ltd, Berwick, Victoria, Australia.

  • Presentations: Portions of this manuscript were presented as a podium presentation at the Surgical Research Society of Australasia 47th Annual Scientific Meeting in Adelaide, South Australia, on 20 November 2009.

  • Clinical Trial Registration: ACTRN12610000932066.

Jacqueline H. Stephens, Discipline of Surgery, The University of Adelaide, The Queen Elizabeth Hospital, 28 Woodville Road, Woodville South, SA 5011, Australia. Email: jacqueline.stephens@adelaide.edu.au

Abstract

Background:  Restoration of bowel continuity after a temporary loop ileostomy following rectal resection often produces impaired bowel function. The purpose of this clinical trial was to assess the efficacy of a probiotic, VSL#3 (VSL Pharmaceuticals Inc., Gaithersburg, MD, USA), in improving bowel function following ileostomy closure.

Methods:  Between March 2005 and April 2008, a prospective, double-blind, placebo-controlled randomized trial of a probiotic preparation was conducted across four South Australian hospitals. Sixty-three patients who underwent a loop ileostomy reversal were randomized to receive 4-week treatment of either probiotic therapy (n= 31) or placebo (n= 32). Bowel symptomology was collected through a patient-completed bowel diary and the Gastrointestinal Quality of Life Index (GIQLI).

Results:  Completion rates of the 4-week therapy regime were similar for both groups: 18 active versus 20 placebos. There was no statistically significant difference in the number of patients who withdrew or had adverse events in the two treatment groups. Reasons for patient withdrawal from the study were similar for both groups. Repeated measures analysis of variance showed no statistically significant difference between the GIQLI scores for the two treatment groups.

Conclusions:  The use of the probiotic preparation, VSL#3, did not alter the post-operative bowel function of patients undergoing loop ileostomy reversal.

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