Register for Combination of 'good' bacteria demonstrated safety and efficacy
Ulcerative ColitisJune 11, 2003
Researchers reported study results that demonstrated treatment with the highly concentrated probiotic preparation, VSL#3, achieved a combined induced remission and/or response rate of 86% in patients with active mild to moderate ulcerative colitis who were not responding to conventional therapy.
"VSL#3 Probiotic Mixture Induces Remission in Patients with Active Ulcerative Colitis" was presented at the annual Digestive Disease Week (DDW) meeting.
Affecting 500,000 Americans, ulcerative colitis (UC) is a form of inflammatory bowel disease that causes the gastrointestinal tract to become red, swollen and ulcerated with sores that eventually bleed. Even if the pathogenesis of UC is not totally clear, there is good evidence to suggest that controlling the balance of the intestinal bacterial flora may be very beneficial for these patients. Numerous clinical studies have shown that the high-concentration probiotic, VSL#3, is effective in controlling and maintaining a healthy balance of the intestinal flora.
"Many ulcerative colitis patients do not respond to conventional treatments and side effects of these medications can be troublesome," said lead investigator Richard Fedorak, MD, professor of medicine and director of the division of gastroenterology at the University of Alberta in Edmonton, Canada. "These results are meaningful because they demonstrate that adding a probiotic with multiple strains and a high concentration of bacteria to the treatment regimen may have the potential to stop this disease in its tracks and avoid any treatment-related side effects."
In the multicenter (Canada, United States and Italy), open-label study, 30 patients with a recent flare-up of mild to moderate UC not responding to conventional medicines were administered four packets of VSL#3 daily (equivalent to 3600 billion good bacteria) for 6 weeks. Eligible patients also remained on steady doses of standard UC therapies including mesalamine, oral corticosteroids and azathioprine.
Remission, the primary endpoint, was achieved in 63% of patients, and 23% of study participants experienced an improvement in symptoms for a combined remission/response rate of 86%. Four patients did not respond to VSL#3, and only 1 patient demonstrated worsened disease activity. No adverse biochemical or clinical effects were observed by adding VSL#3 therapy. Researchers determined the remission and response rates by using the Ulcerative Colitis Clinical Score (UCCS).
Results from the study confirm earlier findings that VSL#3 is effective in the management of serious gastrointestinal disorders such as pouchitis, a major complication following a common surgical procedure in patients with UC. According to the Crohn's and Colitis Foundation of America, approximately 25-40% of patients with UC will require surgery to remove their colon at some time during their illness due to lack of response to treatment. Within 12 months following the surgical intervention and pouch formation, up to 37% of patients experience pouchitis, a syndrome characterized by increased stool frequency and fluidity, rectal bleeding, abdominal cramping, incontinence, and fever.
The lead study published in Gastroenterology reported that VSL#3 is effective in the prevention of pouchitis. According to the accompanying editorial, authored by Jeffry A. Katz, MD, associate professor of medicine, Case Western Reserve University School of Medicine, "Given the similarity between pouchitis and ulcerative colitis, probiotic therapy could also prove useful in the maintenance treatment of this condition."
"When looking at studies of probiotics in treating certain GI disorders, it's important to note that different probiotic preparations contain varying amounts of bacterial strains and strengths," said Fedorak. "We saw positive results with this particular formulation, but the results do not necessarily apply to other probiotics." These differences were noted in Katz's editorial and previously in a letter to the editor of the New England Journal of Medicine. This article was prepared by Gastroenterology Week editors from staff and other reports.
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