Trial on Profermin and Fresubin in Ulcerative Colitis

Phase 2

Completed

• Conditions: Ulcerative Colitis
• Interventions: Other: Profermin; Other: Fresubin

• Registration Number: NCT01193894
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-08-23
• Study First Submitted QC: 2010-09-01
• Study First Posted: 2010-09-02
• Primary Completion: 2012-09
• Study Completion: 2012-12
• Status Verified: 2013-12
• Last Update Submitted: 2013-12-16
• Last Update Posted: 2013-12-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 73

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Profermin	Profermin	-
Fresubin	Fresubin	-

Primary Outcome Measures

Name	Time	Method
Development in Simple Clinical Colitis Activity Index (SCCAI) score	8 and 16 weeks	Clinical significant difference (\>1.5) in course of SCCAI score between the two intervention groups

Secondary Outcome Measures

Name	Time	Method
Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability	20 weeks
Reduction in SCCAI score	8 and 16 weeks	Proportion of patients with a reduction in SCCAI above 1.5, 3.0 and 4.5
Clinical remission	8 and 16 weeks	Proportion of patients in clinical remission (SCCAI=\<2.5)

Trial Locations

Locations (1)

Noreba; 🇩🇰 Allerod, Capital region, Denmark