PMID- 22553401
OWN - NLM
STAT- MEDLINE
DCOM- 20120913
LR  - 20211021
IS  - 2219-2840 (Electronic)
IS  - 1007-9327 (Print)
IS  - 1007-9327 (Linking)
VI  - 18
IP  - 15
DP  - 2012 Apr 21
TI  - Safety and efficacy of Profermin(R) to induce remission in ulcerative colitis.
PG  - 1773-80
LID - 10.3748/wjg.v18.i15.1773 [doi]
AB  - 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.
FAU - Krag, Aleksander
AU  - Krag A
AD  - Gastrounit, Medical Devision 360, Copenhagen University Hospital Hvidovre, 
      Faculty of Health Sciences, Copenhagen University, DK-2650 Hvidovre, Denmark. 
      aleksanderkrag@hotmail.com
FAU - Israelsen, Hans
AU  - Israelsen H
FAU - von Ryberg, Bjorn
AU  - von Ryberg B
FAU - Andersen, Klaus K
AU  - Andersen KK
FAU - Bendtsen, Flemming
AU  - Bendtsen F
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Research Support, U.S. Gov't, Non-P.H.S.
PL  - United States
TA  - World J Gastroenterol
JT  - World journal of gastroenterology
JID - 100883448
RN  - 0 (Complex Mixtures)
RN  - 0 (Lecithins)
RN  - 0 (profermin)
SB  - IM
MH  - Adult
MH  - Avena
MH  - Colitis, Ulcerative/diet therapy/*drug therapy
MH  - Complex Mixtures/*adverse effects
MH  - Female
MH  - Hordeum
MH  - Humans
MH  - Lactobacillus plantarum
MH  - Lecithins/administration & dosage
MH  - Male
MH  - Middle Aged
MH  - Prospective Studies
PMC - PMC3332290
OTO - NOTNLM
OT  - Diet
OT  - Dietary management
OT  - Inflammatory bowel disease
OT  - Medical foods
OT  - Probiotic
OT  - Profer-min(R)
OT  - Ulcerative colitis
EDAT- 2012/05/04 06:00
MHDA- 2012/09/14 06:00
PMCR- 2012/04/21
CRDT- 2012/05/04 06:00
PHST- 2011/08/15 00:00 [received]
PHST- 2011/10/23 00:00 [revised]
PHST- 2012/01/18 00:00 [accepted]
PHST- 2012/05/04 06:00 [entrez]
PHST- 2012/05/04 06:00 [pubmed]
PHST- 2012/09/14 06:00 [medline]
PHST- 2012/04/21 00:00 [pmc-release]
AID - 10.3748/wjg.v18.i15.1773 [doi]
PST - ppublish
SO  - World J Gastroenterol. 2012 Apr 21;18(15):1773-80. doi: 10.3748/wjg.v18.i15.1773.