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Trial on Profermin and Fresubin in Ulcerative Colitis (CUPE2)

This study is currently recruiting participants.
Verified September 2011 by Nordisk Rebalance A/S
Sponsor:
Collaborator:
Hvidovre University Hospital
Information provided by:
Nordisk Rebalance A/S
ClinicalTrials.gov Identifier:
NCT01193894
First received: August 23, 2010
Last updated: September 16, 2011
Last verified: September 2011
History of Changes
  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:

U.S. FDA Resources

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 ]

Estimated Enrollment: 200
Study Start Date: August 2010
Estimated 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

Contacts
Contact: Hans Israelsen, PhD +4548107000 hi@noreba.com

Locations
Denmark
Noreba Recruiting
Allerod, Capital region, Denmark, 3450
Contact: Hans Israelsen, PhD     +4548107000     hi@noreba.com    
Principal Investigator: Aleksander Krag, MD, PhD            
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: Hans Israelsen, Noreba
ClinicalTrials.gov Identifier: NCT01193894     History of Changes
Other Study ID Numbers: CUPE2
Study First Received: August 23, 2010
Last Updated: September 16, 2011
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 May 21, 2013