Trial on Profermin and Fresubin in Ulcerative Colitis (CUPE2)

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: NCT01193894
Recruitment Status : Completed
First Posted : September 2, 2010
Last Update Posted : December 17, 2013
Hvidovre University Hospital
Information provided by (Responsible Party):
Nordisk Rebalance A/S

Brief Summary:
This study aim to investigate the effect of Profermin versus Fresubin in the dietetic treatment of active ulcerative colitis.

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Other: Profermin Other: Fresubin Phase 2 Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Trial on Profermin and Fresubin for Dietetic Treatment of Active Ulcerative Colitis
Study Start Date : August 2010
Actual Primary Completion Date : September 2012
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Profermin Other: Profermin
Medical Food (food for special medical purposes)

Active Comparator: Fresubin Other: Fresubin
Medical food (food for special medical purposes)

Primary Outcome Measures :
  1. Development in Simple Clinical Colitis Activity Index (SCCAI) score [ Time Frame: 8 and 16 weeks ]
    Clinical significant difference (>1.5) in course of SCCAI score between the two intervention groups

Secondary Outcome Measures :
  1. Reduction in SCCAI score [ Time Frame: 8 and 16 weeks ]
    Proportion of patients with a reduction in SCCAI above 1.5, 3.0 and 4.5

  2. Clinical remission [ Time Frame: 8 and 16 weeks ]
    Proportion of patients in clinical remission (SCCAI=<2.5)

  3. Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 20 weeks ]

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Active ulcerative colitis (SCCAI =>5 and <=11)
  • Access to Internet

Exclusion Criteria:

  • Stoma or intestinal resections
  • Recent changes in UC medication
  • Treatment with antibiotics
  • Diabetes
  • Celiac disease
  • Lactose malabsorption

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): NCT01193894

Allerod, Capital region, Denmark, 3450
Sponsors and Collaborators
Nordisk Rebalance A/S
Hvidovre University Hospital
Study Director: Hans Israelsen, PhD Nordisk Rebalance A/S
Principal Investigator: Aleksander Krag, MD, PhD Hvidovre University Hospital
Study Chair: Flemming Bendtsen, MD, DMSci Hvidovre University Hospital

Responsible Party: Nordisk Rebalance A/S Identifier: NCT01193894     History of Changes
Other Study ID Numbers: CUPE2
First Posted: September 2, 2010    Key Record Dates
Last Update Posted: December 17, 2013
Last Verified: December 2013

Keywords provided by Nordisk Rebalance A/S:

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