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NCT01193894 Clinical Trial

Trial on Profermin and Fresubin in Ulcerative Colitis

Ulcerative Colitis Clinical Trial

— CUPE2  

Official title:
A Randomized Trial on Profermin and Fresubin for Dietetic Treatment of Active Ulcerative Colitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01193894
Other study ID # CUPE2
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received August 23, 2010
Last updated December 16, 2013
Start date August 2010
Est. completion date December 2012

Study information
Verified date December 2013
Source Nordisk Rebalance A/S
Contact n/a
Is FDA regulated No
Health authority Regional Veterinary and Food Administration, Region East: Denmark
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 73
Est. completion date December 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Profermin
Medical Food (food for special medical purposes)
• Fresubin
Medical food (food for special medical purposes)

Locations
Country Name City State
Denmark Noreba Allerod Capital region

Sponsors (2)
Lead Sponsor Collaborator
Nordisk Rebalance A/S Hvidovre University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Development in Simple Clinical Colitis Activity Index (SCCAI) score Clinical significant difference (>1.5) in course of SCCAI score between the two intervention groups 8 and 16 weeks No
Secondary Reduction in SCCAI score Proportion of patients with a reduction in SCCAI above 1.5, 3.0 and 4.5 8 and 16 weeks No
Secondary Clinical remission Proportion of patients in clinical remission (SCCAI=<2.5) 8 and 16 weeks No
Secondary Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability 20 weeks Yes
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