A highly concentrated probiotic preparation may be an effective treatment for ulcerative colitis patients who fail to respond to conventional medicine, reported researchers in the US yesterday.
The patented probiotic therapy VSL#3 achieved a combined induced remission and/or response rate of 86 per cent in patients with active mild to moderate ulcerative colitis who were not responding to conventional therapy, according to the research presented at the annual Digestive Disease Week (DDW) meeting in Florida.
Ulcerative colitis (UC) is a form of inflammatory bowel disease that causes the gastrointestinal tract to become red, swollen and develop sores that eventually bleed. While the pathogenesis of UC is not fully established, there is evidence to suggest that controlling the balance of the intestinal bacterial flora may be beneficial for these patients.
"Many ulcerative colitis patients do not respond to conventional treatments and side effects of these medications can be troublesome," said lead investigator Dr Richard Fedorak, 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."
VSL#3, marketed by VSL Pharmaceuticals, contains numerous strains of bacteria at high concentrations (450 billion).
In the multi-centre (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 given four packets of VSL#3 daily (equivalent to 3,600 billion good bacteria) for six 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 per cent of patients, and 23 per cent of study participants experienced an improvement in symptoms for a combined remission/response rate of 86 per cent. (This was determined using the Ulcerative Colitis Clinical Score.) Four patients did not respond to VSL#3, and only one patient demonstrated worsened disease activity, reported the researchers. No adverse biochemical or clinical effects were observed.
VSL#3 has previously been shown to help in the management of serious gastrointestinal disorders. A study published in the May 2003 edition of the journal Gastroenterology reported that VSL#3 is effective in the prevention of pouchitis, a major complication following a common surgical procedure in patients with UC. In an accompanying editorial, Dr Jeffry A. Katz, associate professor of medicine from the Case Western Reserve University School of Medicine, wrote: "Given the similarity between pouchitis and ulcerative colitis, probiotic therapy could also prove useful in the maintenance treatment of this condition."
But Dr Fedorak noted: "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. We saw positive results with this particular formulation, but the results do not necessarily apply to other probiotics."
DDW continues until 22 May 2003 in Orlando, Florida. The meeting showcases approximately 5,000 abstracts and hundreds of lectures on the latest advances in GI research, medicine and technology.