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World J Gastroenterol. 2012 Apr 21;18(15):1773-80. doi: 10.3748/wjg.v18.i15.1773.

Safety and efficacy of Profermin® to induce remission in ulcerative colitis.

Author information

1
Gastrounit, Medical Devision 360, Copenhagen University Hospital Hvidovre, Faculty of Health Sciences, Copenhagen University, DK-2650 Hvidovre, Denmark. aleksanderkrag@hotmail.com

Abstract

AIM:

To test the efficacy and safety of Profermin(®) 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(®) 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(®) was generally well tolerated.

CONCLUSION:

Profermin(®) is safe and may be effective in inducing remission of active UC.

KEYWORDS:

Diet; Dietary management; Inflammatory bowel disease; Medical foods; Probiotic; Profer-min®; Ulcerative colitis

PMID:
22553401
PMCID:
PMC3332290
DOI:
10.3748/wjg.v18.i15.1773
[Indexed for MEDLINE]
Free PMC Article

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