Abbreviation: N, number of subjects in trial.

Abbreviation: N, number of subjects in trial.

evaluated using an open label design (91). In this pilot study, 20 patients in remission were treated for 12 months. At the end of the trial 15 out of 20 patients (75%) remained in remission.

A recent study has investigated the use of Saccharomyces boulardii in the setting of ulcerative colitis. In an open, non-placebo controlled study, 25 patients with a relapse of ulcerative colitis were treated with mesalazine in combination with S. boulardii. Seventeen patients achieved remission (93).

Trials in Pouchitis

Convincing evidence for beneficial probiotic effects in inflammatory bowel disease is seen in the treatment of pouchitis. In an open labeled study, patients with pouchitis were treated with Lactobacillus GG and fructooligosaccharide (94). The patients reported a beneficial effect when the probiotic-prebiotic mix was administered as an adjuvant to antibiotic therapy. Remission was documented by suppression of symptom scores and reversal of endoscopic findings (94). Gionchetti et al. (95) have studied VSL#3 in the setting of pouchitis and have demonstrated the efficacy of this probiotic mix in maintenance of remission in patients with chronic pouchitis. In a randomized, doubleblind, placebo-controlled trial, 40 patients with pouchitis received one month of antibiotic treatment and were in clinical and endoscopic remission. Patients were then randomized to receive VSL#3 or placebo for 9 months. At the end of the study three patients (15%) had relapsed in the VSL#3 group compared to 20 (100%) in the placebo group. In a follow-up study, this group has also used VSL#3 as prophylaxis in patients after ileo-anal pouch formation surgery to prevent pouchitis. Forty patients were randomized to receive VSL#3 or placebo. At 1-year follow-up, 10% of probiotic treated patients had developed pouchitis, compared with 40% of the placebo treated group (96). A recent study has again examined the role of VSL#3 in maintaining remission following treatment of refractory or recurrent pouchitis. Thirty-six patients with recurrent pouchitis (at least twice in the past year) or requiring continuous antibiotics, in whom remission was induced by 4 weeks of antibiotics, were randomized to receive

Table 4 Summary of Human Trials of Probiotic Therapy in Pouchitis

Study type

Organism used

Trial outcome


Open labeled

Prebiotic fructooli-

Effective in inducing remission in

Friedman et al.


gosaccharide and

combination with antibiotic

2000 (94)

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