Normal intestinal bacteria have been implicated in the initiation and perpetuation of inflammatory bowel disease (IBD) in genetically predisposed individuals
Certain probiotic species when consumed in appropriate amounts have properties possibly effective in the dietary management of IBD3-6
To evaluate the efficacy of VSL#3 in the dietary management of active ulcerative colitis (UC) in patients not responding to conventional therapy as measured by the Ulcerative Colitis Disease Activity Index (UCDAI) after 6 weeks of intake
Evaluate the safety of VSL#3
Evaluate modification of gut flora by VSL#3
Thirty-four ambulatory patients with active UC received open-label VSL#3®, 3600 billion bacteria daily for 6 weeks
The presence of biopsy-associated bacteria was detected using a nucleic acid-based method; VSL#3 species was detected by DNA sequencing of 16S rRNA1
In patients consuming VSL#3 some of the probiotic bacteria were detected in mucosal biopsies, indicating the retention of beneficial bacteria in the gut
In patients not responding to conventional therapy who consumed VSL#3:
Intent-to-treat analysis demonstrated remission (UCDAI < 2) in 53% (n=18); response (decrease in UCDAI > 3, but final score > 3) in 24% (n=8);
no response in 9% (n=3);
worsening in 9% (n=3); and
failure to complete the final sigmoidoscopy assessment in 5% (n=2)1
There were no biochemical or clinical adverse events related to VSL#3
At least some of the bacterial species incorporated in the probiotic product reached the target site in amounts that could be detected.
In patients with mild to moderate UC who failed to respond to conventional therapy, consumption of VSL#3 resulted in:
-77% Combined Remission/Response rate
-VSL#3® provided benefit beyond that seen with other conventional therapy
-No adverse events were noted other than mild bloating
VSL#3 is a medical food for the dietary management of ulcerative colitis or an ileal pouch.
American Journal of Gastrolenterology - Am J Gastroenterol. 2005;100:1539-1546.
Rodrigo Bibiloni, Ph.D., Richard N. Fedorak, M.D., Gerald W. Tannock, Ph.D., Karen L. Madsen, Ph.D., Paolo Gionchetti, M.D., Massimo Campieri, M.D., Claudio De Simone, Ph.D., and R. Balfour Sartor, M.D. Department of Agricultural, Food and Nutritional Science; and Division of Gastroenterology, University of Alberta, Edmonton, Alberta, Canada; Division of Gastroenterology, University of Bologna, Bologna, Italy; University of L'Aquila, L'Aquila, Italy; and Division of Gastroenterology and Division of Hepatology, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina