期刊
WORLD JOURNAL OF GASTROENTEROLOGY
卷 18, 期 15, 页码 1773-1780出版社
BAISHIDENG PUBL GRP CO LTD
DOI: 10.3748/wjg.v18.i15.1773
关键词
Ulcerative colitis; Diet; Probiotic; Profermin (R); Inflammatory bowel disease; Dietary management; Medical foods
资金
- Danish Food Industry Agency under Ministry of Food, Agriculture and Fisheries [3414-06-01530]
- Nordisk Rebalance
AIM: To test the efficacy and safety of Profermin (R) in inducing remission in patients with active ulcerative colitis (UC). METHODS: The study included 39 patients with mild to moderate UC defined as a Simple Clinical Colitis Activity Index (SCCAI) > 4 and < 12 (median: 7.5), who were treated open-label with Profermin (R) twice daily for 24 wk. Daily SCCAI was reported observer blinded via the Internet. RESULTS: In an intention to treat (ITT) analysis, the mean reduction in SCCAI score was 56.5%. Of the 39 patients, 24 (62%) reached the primary endpoint, which was proportion of patients with >= 50% reduction in SCCAI. Our secondary endpoint, the proportion of patients in remission defined as SCCAI <= 2.5, was in ITT analysis reached in 18 of the 39 patients (46%). In a repeated-measure regression analysis, the estimated mean reduction in score was 5.0 points (95% CI: 4.1-5.9, P < 0.001) and the estimated mean time taken to obtain half the reduction in score was 28 d (95% CI: 26-30). There were no serious adverse events (AEs) or withdrawals due to AEs. Profermin (R) was generally well tolerated. CONCLUSION: Profermin (R) is safe and may be effective in inducing remission of active UC. (C) 2012 Baishideng. All rights reserved.
作者
我是这篇论文的作者
点击您的名字以认领此论文并将其添加到您的个人资料中。
推荐
暂无数据