Profermin® in Active Ulcerative Colitis

Nordisk Rebalance A/S39 enrolled

Overview

In this study the investigators aim was to investigate the safety and possible efficacy of Profermin® in patients with ulcerative colitis. The investigators also aimed at assessing the usefulness of a new online daily symptom registration system.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Ulcerative Colitis

Interventions

ProferminOTHER

Medical Food (food for special medical purposes)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria:Patients were eligible if they were between 18 and 50 years of age and had an established diagnosis of UC based on clinical, endoscopic and histological features. Active disease was assessed by Simple Clinical Colitis Activity Index (SCCAI) (Table 1) score above 4 and below 12. \- Exclusion Criteria: Patients who initiated treatment with azathioprine, 6-mercaptopurine, ciclosporin or methotrexate within 8 weeks prior to inclusion or TNF-α inhibitors within 12 weeks before inclusion or had changes in UC treatment within 2 weeks before inclusion were ineligible for the study. Concomitant coeliac disease or lactose intolerance were also exclusion criteria. In addition any malignant or premalignant condition or recent gastroenteritis rendered patients ineligible-

Outcomes

Primary Outcomes

Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI ≥50%.

Daily report of SCCAI symptoms on the Internet

Time frame: 24 weeks

Secondary Outcomes

Our secondary endpoint was to estimate the proportion of patients in remission defined as SCCAI lower than or equal to 2.5

Daily report of SCCAI symptoms on the Internet

Time frame: 24 weeks

Data from ClinicalTrials.gov

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