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Trial on Profermin and Fresubin in Ulcerative Colitis (CUPE2)

Primary Purpose

Ulcerative Colitis

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Profermin
Fresubin
Sponsored by
Nordisk Rebalance A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring IBD, UC, Profermin, Fresubin, Probiotics, Dietetic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Noreba

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Profermin

Fresubin

Arm Description

Outcomes

Primary Outcome Measures

Development in Simple Clinical Colitis Activity Index (SCCAI) score
Clinical significant difference (>1.5) in course of SCCAI score between the two intervention groups

Secondary Outcome Measures

Reduction in SCCAI score
Proportion of patients with a reduction in SCCAI above 1.5, 3.0 and 4.5
Clinical remission
Proportion of patients in clinical remission (SCCAI=<2.5)
Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Full Information

First Posted
August 23, 2010
Last Updated
December 16, 2013
Sponsor
Nordisk Rebalance A/S
Collaborators
Hvidovre University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01193894
Brief Title
Trial on Profermin and Fresubin in Ulcerative Colitis
Acronym
CUPE2
Official Title
A Randomized Trial on Profermin and Fresubin for Dietetic Treatment of Active Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nordisk Rebalance A/S
Collaborators
Hvidovre University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
IBD, UC, Profermin, Fresubin, Probiotics, Dietetic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Profermin
Arm Type
Experimental
Arm Title
Fresubin
Arm Type
Active Comparator
Intervention Type
Other
Intervention Name(s)
Profermin
Intervention Description
Medical Food (food for special medical purposes)
Intervention Type
Other
Intervention Name(s)
Fresubin
Intervention Description
Medical food (food for special medical purposes)
Primary Outcome Measure Information:
Title
Development in Simple Clinical Colitis Activity Index (SCCAI) score
Description
Clinical significant difference (>1.5) in course of SCCAI score between the two intervention groups
Time Frame
8 and 16 weeks
Secondary Outcome Measure Information:
Title
Reduction in SCCAI score
Description
Proportion of patients with a reduction in SCCAI above 1.5, 3.0 and 4.5
Time Frame
8 and 16 weeks
Title
Clinical remission
Description
Proportion of patients in clinical remission (SCCAI=<2.5)
Time Frame
8 and 16 weeks
Title
Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time Frame
20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hans Israelsen, PhD
Organizational Affiliation
Nordisk Rebalance A/S
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Aleksander Krag, MD, PhD
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Flemming Bendtsen, MD, DMSci
Organizational Affiliation
Hvidovre University Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Noreba
City
Allerod
State/Province
Capital region
ZIP/Postal Code
3450
Country
Denmark

12. IPD Sharing Statement

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Trial on Profermin and Fresubin in Ulcerative Colitis

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