The efficacy of a non-pathogenic strain of Escherichia coli Nissle 1917 in the treatment of IBD has been tested in three recent trials. In the other three controlled studies, E. coli Nissle 1917 has been found to exhibit efficacy similar to that of mesalazine in maintenance treatment of ulcerative colitis (UC) [20-22].
We have explored another strategy, using a probi-otic preparation (VSL#3) characterised by very high bacterial concentration (each packet containing 450 billion viable bacteria) and the presence of a cocktail of eight different bacterial species. This product contains viable lyophilised bacteria of four strains of Lactobacilli (L. casei, L. plantarum, L. acidophilus, L. delbrueckii subsp. Bulgaricus), three strains of Bifi-dobacteria (B. longum, B. breve, B. infantis) and one strain of Streptococcus salivarius subsp. Ther-mophilus.
We carried-out a pilot study using VSL#3 as maintenance treatment in patients with UC in remission, who are allergic or intolerant to sulphasalazine and mesalazine, to verify the impact on the faecal flora of this preparation. Twenty patients received 6 g per day of VSL#3 (1 800 billion bacteria) for 12 months and were assessed clinically and endoscopically at baseline and at 6 and 12 months or in case of relapse. Stool culture and determination of faecal pH were also performed at different intervals.
Microbiological determination showed a significant increase in concentration of Lactobacilli, Bifi-dobacteria and Streptococcus thermophilus, which was already evident after 20 days and persisted through the treatment period with return to basal levels within 15 days after stopping the treatment without modification of the faecal concentration of Bacteroides, Enterococci, Coliforms, Clostridia and the total anaerobes and aerobes. Faecal pH was significantly reduced by the treatment and 15 of the 20 patients (75%) remained in remission .
In an uncontrolled pilot study VSL#3, at a very high dose (3 600 billion), was able to induce remission in 63%, with a positive response in another 23% of patients with active mild-to-moderate disease . Similarly, in an open, uncontrolled 4-week study, the yeast Saccharomyces boulardii induced remission in 71% of patients with mild to moderate ulcerative colitis .
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