Trial on Profermin and Fresubin in Ulcerative Colitis

Phase 3CompletedNCT01193894

Nordisk Rebalance A/S73 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcerative Colitis

Interventions

ProferminOTHER

Medical Food (food for special medical purposes)

FresubinOTHER

Medical food (food for special medical purposes)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Noreba

Allerød Municipality, Capital Region, Denmark

Outcomes

Primary Outcomes

Development in Simple Clinical Colitis Activity Index (SCCAI) score

Clinical significant difference (\>1.5) in course of SCCAI score between the two intervention groups

Time frame: 8 and 16 weeks

Secondary Outcomes

Reduction in SCCAI score

Proportion of patients with a reduction in SCCAI above 1.5, 3.0 and 4.5

Time frame: 8 and 16 weeks

Clinical remission

Proportion of patients in clinical remission (SCCAI=\<2.5)

Time frame: 8 and 16 weeks

Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability

Time frame: 20 weeks

Data from ClinicalTrials.gov

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