In a double-blind study, we have compared the efficacy of VSL#3 with placebo in the maintenance treat ment of chronic pouchitis. Forty patients who obtained clinical and endoscopic remission after 1 month of combined antibiotic treatment (rifaximin 2 g/day plus ciprofloxacin 1 g/day) were randomised to receive VSL#3 6 g daily (1 800 billion bacteria/day) or an identical appearing placebo for 9 months. Clinical assessment was done every month; endoscopic and histological assessment were performed at entry and every 2 months thereafter. Stool culture was done before and after antibiotic treatment and subsequently every month during maintenance treatment. Relapse was defined as an increase of at least 2 points in the clinical portion of pouchitis activity index that should be confirmed endoscopically and histologi-cally. All the 20 patients treated with placebo had a relapse in the follow-up period; in contrast 17 of the 20 (85%) patients treated with VSL#3 were still in remission after 9 months. Interestingly, all these 17 patients had a relapse within 4 months after suspension of the active treatment. Faecal concentration of Lactobacilli, Bifidobacteria and Streptococcus sali-varius subsp. Thermophilus were significantly increased within 1 month after starting VSL#3 treatment and remained stable throughout the study. However, this increase did not affect concentration of the other bacterial groups, suggesting that the effect was not mediated by suppression of endogenous luminal bacteria [26]. These results have been recently replicated by a study evaluating the efficacy of VSL#3 in maintaining antibiotic-induced remission (obtained after a 1-month treatment with metronidazole 800 mg/day plus ciprofloxacin 1 g/day) for 1 year in patients with refractory or recurrent pouchitis: 20 patients received VSL#3 1 800 billion bacteria once a day for one year and 16 patients received a placebo during the same period. Clinical, endoscopic and histological evaluations were made before, 2 and 12 months after the randomisation. A parallel assessment of the quality of life (QoL) was obtained with IBDQ. This study has substantially confirmed the observations made previously, with maintenance remission rate at 1 year for 85% in the VSL#3 group and 6% in the placebo group. A high QoL score was obtained by the group treated with VSL#3 [27].

As regards the mechanisms of action, in these patients we found that continuous administration of VSL#3 determined a significant increase of IL-10 tissue levels together with a significant decrease of tissue levels of the pro-inflammatory cytokines TNF alfa, IL-1 and IFN gamma, and a decrease of matrix metalloproteinase activity [28]. On the other hand, Lactobacillus GG was ineffective in preventing relapses in patients with chronic pouchitis in a placebo-controlled trial [29].

We have also carried-out a double-blind placebo controlled trial to evaluate the efficacy of VSL#3 in the prevention of pouchitis onset in patients operated for ileal pouch-anal anastomosis (IPAA) for UC. Within 1 week after ileostomy closure, 40 patients, were randomised to receive VSL#3 3 g per day (900 billion bacteria/day) or an identical placebo for 12 months; patients were assessed clinically endoscopi-cally and histologically at 1,3,6,9,12 months according to PDAI.

Patients treated with VSL#3 had a significantly lower incidence of acute pouchitis compared to those treated with placebo during the first year after ileostomy closure (10 vs. 40%; p<0.05). Moreover, IBDQ was significantly improved only in the group treated with VSL#3, and median stool frequency in patients who did not develop pouchitis, was significantly less in the VSL#3 group compared to the placebo group [30].

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