The term "probiotic" refers to "living organisms, which upon ingestion in certain numbers, exert health benefits beyond inherent basic nutrition" . Recent observations have suggested a potential therapeutic role for probiotics in inflammatory bowel diseases (IBD), based on convincing evidence implicating intestinal bacteria in their pathogenesis .
On the basis of this information, we carried out a double-blind study comparing the efficacy of a highly concentrated probiotic preparation, VSL#3 (450 billion bacteria of eight different strains; VHS Phar-ma, USA) vs. placebo in maintenance treatment of chronic relapsing pouchitis. In our study, 40 patients who obtained clinical and endoscopic remission after one month of combined antibiotic treatment (rifax-imin 2 g/day plus ciprofloxacin 1 g/day), were randomised to receive either VSL#3, 6 g/day (1 800 billion bacteria per day), or an identical-appearing placebo for 9 months. Relapse was defined as an increase of at least 2 points in the clinical portion of PDAI, which should be confirmed by endoscopy and histology. All the 20 patients who received the placebo relapsed; in contrast 17 of the 20 patients (85%) treated with VSL#3 were still in remission at the end of the study. All the 17 patients had a relapse within 4 months after suspension of the treatment. The results of this study suggested that oral administration of this highly concentrated probiotic preparation is effective in preventing relapse of chronic pouchitis, enhancing the concentration of protective bacteria and their metabolic activities in the ileal pouch .
These results have been recently confirmed by a study evaluating the efficacy of a single, daily dose of VSL#3 in maintaining antibiotic-induced remission (obtained after a 1 month treatment with metronida-zole 800 mg/day plus ciprofloxacin 1 g/day) for 1 year in patients with refractory or recurrent pouchitis: 20 patients received VSL#3 at 1 800 billion bacteria once a day for 1 year and 16 patients received a placebo during the same period. Clinical, endoscopic and his-tological evaluations were made before 2 and 12 months after the randomisation. A parallel assessment of quality of life (QoL) was obtained with IBDQ. This study has substantially confirmed the observations made previously, with a maintenance remission rate of 85% at 1 year in the VSL#3 group and 6% in the placebo group. A high rating in the QoL score was obtained by the group treated with VSL#3 .
The same probiotic preparation was also more recently shown to be significantly superior to placebo in the prevention of pouchitis onset within the first year after surgery in a randomised double-blind placebo-controlled study. Forty consecutive patients who underwent IPAA for UC were randomised within a week after ileostomy closure, and received VSL#3 at a dosage of 3 g per day or an identical placebo for 12 months. They were assessed clinically, endoscopi-cally, histologically at 1, 3, 6, 9 and 12 months, according to PDAI; QoL was also assessed at baseline at the end of the study. Patients treated with VSL#3 had a significantly lower incidence of acute pouchitis (10%) compared with those treated with placebo (40%) (p<0.05), and they experienced a significant improvement in quality of life, whereas this did not happen in the placebo group, indicating the effectiveness of a highly concentrated probiotic preparation in preventing pouchitis onset during the first year after surgery .
Preliminary data of a pilot study to evaluate the efficacy of high dosage of VSL#3 (6 g b.i.d. equivalent to 3 600 billion bacteria per day) administered for 1 month as treatment for mildly active pouchitis (PDAI score 7-12), have shown its potential usefulness in improving active pouch inflammation and health related quality of life .
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