P588. A randomized double blind placebo controlled trial to assess the efficacy of a probiotic preparation as maintenance therapy in patients with ulcerative colitis
Y. Suzuki1, A. Yamada1, Y. Yoshimatsu1, K. Takeuchi1, 1Sakura Medical Center, Toho University, Internal Medicine, Sakura city, Japan
Probiotics are live microorganisms which when administered in adequate amounts are expected to produce therapeutic effects in the gut. Based on this knowledge, commercially prepared probiotics have become available for patients with inflammatory bowel diseases (IBD). However, the opinion on the clinical benefit of probiotics in patients with IBD is yet to be unified. In this study, we were interested to see if administration of a probiotc impacts clinical and endoscopic relapse in patients with quiescent ulcerative colitis (UC).
In this placebo controlled study, we set to evaluate the clinical efficacy of the probiotic, BIO-THREE. Each tablet of this preparation contains 2 mg Streptococcus faecalis, 10 mg Clostridium butyricum and Bacillus mesenterium. Sixty outpatients with quiescent UC were randomly assigned to two groups: receiving 9 BIO-THREE tablets per day for 12 months (group I, n = 30) or receiving 9 placebo (lactose) tablets per day for 12 months (group II, n = 30). Patients in both groups could continue with their ongoing medications. Patients' symptoms were evaluated at every hospital visit up to 12 months. Further, the “Terminal Restriction Fragment Length Polymorphism” (T-RFLP), which is a molecular biology technique for profiling microbial communities was applied to the faecal microflora.
In group I, 7 patients were excluded by criteria, and 23 patients were available for evaluation. Similarly, in group II, 7 patients were excluded and 23 could be assessed. The overall rates of sustained clinical and endoscopic remission after 12 months were 69.5% in group I and 56.6% in group II, indicating some clinical benefit in favour of BIO-THREE. T-RFLP together with cluster analyses were applied to calculate the distances of similarity among patients' faecal samples as correlation coefficients, and represented graphically by a dendrogram for interpretation. The efficacy in preventing relapse for BIO-THREE was calculated from ARR (absolute risk reduction) and NNT (number needed to treat). Patients whose faecal bacterial clustering by T-RFLP was I seemed to benefit most from probiotics, suggesting that there are responder as well as non-responder subgroups among UC patients.
In this placebo controlled study, BIO-THREE showed benefit in the prevention of UC relapse. However, T-RFLP analysis should determine a biomarker of response to probiotics and vice versa. This should help to avoid futile use of probiotics in clinical settings.