首页|Safety and efficacy of Profermin（R） to induce remission in ulcerative colitis

Safety and efficacy of Profermin（R） to induce remission in ulcerative colitis

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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.

Ulcerative colitisDietProbioticProfermin(R)Inflammatory bowel diseaseDietary managementMedical foods

Aleksander Krag、Hans Israelsen、Bjφrn von Ryberg、Klaus K Andersen、Flemming Bendtsen

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Gastrounit, Medical Devision 360, Copenhagen University Hospital Hvidovre, Faculty of Health Sciences, Copenhagen University, DK-2650 Hvidovre,Denmark

Nordisk Rebalance A/S, M.D.Madsensvej 14-16, DK-3450 Allerφd, Denmark

Statistics Section, Informatics and Mathematical Modelling, Technical University of Denmark, DK-2800Lyngby, Denmark

Danish Innovation Law GrantDanish Food Industry Agency under the Ministry of Food,Agriculture and FisheriesNordisk Rebalance,who developed and manufactured Profermin®,and partly financed the study

J.nr.3414-06-01530

2012

10.3748/wjg.v18.i15.1773

世界胃肠病学杂志(英文版)
太原消化病研治中心

世界胃肠病学杂志(英文版)

SCI
影响因子：1.001
ISSN：1007-9327
年,卷(期)：2012.18(15)
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