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Fedorak et al1 evaluated the efficacy of VSL#3 in an open-label, two-center trial with 30 patients with active mild to moderate ulcerative colitis. These patients had failed mesalamine therapy and were treated with VSL#3 (1.2 x 1012 cfu daily in two divided doses) for 6 weeks.
Remission, as determined by an ulcerative colitis clinical score of < 3, was achieved in 63% of VSL#3-treated patients. Response, as determined as an ulcerative colitis clinical score of a decrease of [less than or equal to] 3 and a final value of [greater than or equal to] 3, was achieved in 23% of VSL#3-treated patients. No response was found in 13% of the treated patients. This represents a significant improvement in a difficult to treat population. A randomized, controlled trial is underway to confirm these results.
Guslandi et al2 studied 25 patients with a clinical flare of their ulcerative colitis of a mild to moderate degree, according to Truelove and Witts' criteria. The patients were on maintenance mesalamine (3 g per day) for at least 3 months. Only patients who had a history of poorly tolerating corticosteroids were permitted to enter the study. In this open-label trial, patients received Saccharomyces boulardii (750 mg per day in three divided doses) for 4 weeks while their ongoing mesalamine was continued. Clinical disease activity score, before and after probiotic therapy, was determined by the Rackmilewitz ulcerative colitis activity index; it is calculated on the basis of stool frequency, blood in the stool, general condition, fever, abdominal pain, erythrocyte sedimentation rate, and hemoglobin values.
A significant reduction in the ulcerative colitis activity index score was observed at the end of treatment (p < 0.05), and remission (a disease activity score [less than or equal to] 5) was achieved in 17 of 25 patients (68%).47 Interestingly, the remission rate in this pilot study is remarkably similar to the remission rates described for VSL#3.
Venturi et al3 examined 20 patients with ulcerative colitis who were intolerant or allergic to 5-aminosalicylic acid (ASA). Patients were in clinical, endoscopic, and histologic remission following treatment with corticosteroids for a recent acute flare within the previous 3 months. Patients received open-label VSL#3 (1 x 1012 cfu daily in two divided doses) for 12 months. Patients were assessed clinically every 2 months and assessed endoscopically at 6 and 12 months. In this study, clinical remission was defined as absence of visible blood in the stools and no more than two bowel movements per day. Endoscopic remission was defined as a score of zero in accordance with the Baron's ulcerative colitis index.
Fifteen of 20 treated patients (75%) remained in remission at the end or 12 months of study.7 Once again, significant concentrations of the probioties present in the VSL#3 were identified in fecal cultures. There were no significant changes in fecal concentration of Bacteroides, clostridia, conforms, or total aerobic and anaerobic bacteria.
Ishikawa et a14 conducted a randomized, controlled trial study in 21 patients to examine the effect of bifidobacteria-fermented milk in patients with ulcerative colitis in remission. Patients received fermented milk (Yakult, Yakult Honsha Co., Ltd, Tokyo, Japan) that contained live bifidobacteria (Bifidabacterium breve and Bifidobacterium bifidum) and Lactobacillus acidophilus (1 x 1010 cfu per 100 mL once daily) for 12 months. Remission was defined clinically as any global increase in symptoms. Compliance at the 95% level was limited to 7 out of 11 patients consuming the fermented milk product.
At the end of 12 months, clinical remission was seen in 8 out of 11 subjects (73%) taking the fermented milk and in 1 out of 10 subjects (10%) taking placebo.52 Interestingly, despite this significant difference in clinical remission rates, there were no significant differences in the colonoscopic findings at 1 year. This raises the question as to the validity of the clinical assessment tool used in this trial. Furthermore, there were no differences between the two groups in total fecal bacterial counts or in bifidobacteria counts. However, the authors were able to recover (from the feces) the bifidobacteria strains present in the fermented milk. A larger, multicenter study with this probiotic product is currently underway.