Trial on Profermin and Fresubin in Ulcerative Colitis (CUPE2)

This study has been completed.
Sponsor:
Collaborator:
Hvidovre University Hospital
Information provided by (Responsible Party):
Nordisk Rebalance A/S
ClinicalTrials.gov Identifier:
NCT01193894
First received: August 23, 2010
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Ulcerative Colitis
Other: Profermin
Other: Fresubin
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Trial on Profermin and Fresubin for Dietetic Treatment of Active Ulcerative Colitis

Resource links provided by NLM:


Further study details as provided by Nordisk Rebalance A/S:

Primary Outcome Measures:
  • Development in Simple Clinical Colitis Activity Index (SCCAI) score [ Time Frame: 8 and 16 weeks ] [ Designated as safety issue: No ]
    Clinical significant difference (>1.5) in course of SCCAI score between the two intervention groups


Secondary Outcome Measures:
  • Reduction in SCCAI score [ Time Frame: 8 and 16 weeks ] [ Designated as safety issue: No ]
    Proportion of patients with a reduction in SCCAI above 1.5, 3.0 and 4.5

  • Clinical remission [ Time Frame: 8 and 16 weeks ] [ Designated as safety issue: No ]
    Proportion of patients in clinical remission (SCCAI=<2.5)

  • Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: 20 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 73
Study Start Date: August 2010
Study Completion Date: December 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Profermin Other: Profermin
Medical Food (food for special medical purposes)
Active Comparator: Fresubin Other: Fresubin
Medical food (food for special medical purposes)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01193894

Locations
Denmark
Noreba
Allerod, Capital region, Denmark, 3450
Sponsors and Collaborators
Nordisk Rebalance A/S
Hvidovre University Hospital
Investigators
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
  More Information

No publications provided

Responsible Party: Nordisk Rebalance A/S
ClinicalTrials.gov Identifier: NCT01193894     History of Changes
Other Study ID Numbers: CUPE2
Study First Received: August 23, 2010
Last Updated: December 16, 2013
Health Authority: Regional Veterinary and Food Administration, Region East: Denmark

Keywords provided by Nordisk Rebalance A/S:
IBD
UC
Profermin
Fresubin
Probiotics
Dietetic

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

ClinicalTrials.gov processed this record on April 15, 2014