Profermin® in Active Ulcerative Colitis (CUPE-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01245465
Recruitment Status : Completed
First Posted : November 22, 2010
Last Update Posted : November 23, 2010
Hvidovre University Hospital
Information provided by:
Nordisk Rebalance A/S

Brief Summary:
In this study the investigators aim was to investigate the safety and possible efficacy of Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing the usefulness of a new online daily symptom registration system.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: Profermin Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Profermin® to Induce Remission in Patients With Ulcerative Colitis
Study Start Date : January 2009
Actual Primary Completion Date : November 2009
Actual Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Profermin
Daily oral intake of a food for special medical purposes (Profermin)
Other: Profermin
Medical Food (food for special medical purposes)

Primary Outcome Measures :
  1. Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI ≥50%. [ Time Frame: 24 weeks ]
    Daily report of SCCAI symptoms on the Internet

Secondary Outcome Measures :
  1. Our secondary endpoint was to estimate the proportion of patients in remission defined as SCCAI lower than or equal to 2.5 [ Time Frame: 24 weeks ]
    Daily report of SCCAI symptoms on the Internet

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:Patients were eligible if they were between 18 and 50 years of age and had an established diagnosis of UC based on clinical, endoscopic and histological features. Active disease was assessed by Simple Clinical Colitis Activity Index (SCCAI) (Table 1) score above 4 and below 12.

Exclusion Criteria:

Patients who initiated treatment with azathioprine, 6-mercaptopurine, ciclosporin or methotrexate within 8 weeks prior to inclusion or TNF-α inhibitors within 12 weeks before inclusion or had changes in UC treatment within 2 weeks before inclusion were ineligible for the study. Concomitant coeliac disease or lactose intolerance were also exclusion criteria. In addition any malignant or premalignant condition or recent gastroenteritis rendered patients ineligible-

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01245465

Sponsors and Collaborators
Nordisk Rebalance A/S
Hvidovre University Hospital
Study Director: Hans Israelsen, PhD Nordisk Rebalance A/S

Responsible Party: Hans Israelsen, Noreba Identifier: NCT01245465     History of Changes
Other Study ID Numbers: H-B-2008-FSP-20
First Posted: November 22, 2010    Key Record Dates
Last Update Posted: November 23, 2010
Last Verified: November 2010

Additional relevant MeSH terms:
Colitis, Ulcerative
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases