title: Safety and efficacy of Profermin® to induce remission in ulcerative colitis.
abstract: OBJECTIVE
  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.
  
  
  CONCLUSIONS
  Profermin(®) is safe and may be effective in inducing remission of active UC.
authors.affiliation: Gastrounit, Medical Devision 360, Copenhagen University Hospital Hvidovre, Faculty of Health Sciences, Copenhagen University, DK-2650 Hvidovre, Denmark. aleksanderkrag@hotmail.com
authors.forename: Aleksander
authors.initials: A
authors.lastname: Krag
authors.forename: Hans
authors.initials: H
authors.lastname: Israelsen
authors.forename: Bjørn
authors.initials: B
authors.lastname: von Ryberg
authors.forename: Klaus K
authors.initials: KK
authors.lastname: Andersen
authors.forename: Flemming
authors.initials: F
authors.lastname: Bendtsen
mesh_terms: D000328:Adult; D018554:Avena; D003093:Colitis, Ulcerative / Q000178:diet therapy / Q000188:drug therapy*; D045424:Complex Mixtures / Q000009:adverse effects*; D005260:Female; D001467:Hordeum; D006801:Humans; D048191:Lactiplantibacillus plantarum; D054709:Lecithins / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies
chemical_list: D045424:Complex Mixtures; D054709:Lecithins; C574856:profermin