Profermin® in Active Ulcerative Colitis (CUPE-1)

Nordisk Rebalance

Status and phase: Completed; Phase 2; Phase 1

Conditions: Ulcerative Colitis

Treatments: Other: Profermin

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01245465

H-B-2008-FSP-20

Details and patient eligibility

About

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.

Enrollment: 39 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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-

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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39 participants in 1 patient group

Profermin

Experimental group

Description:

Daily oral intake of a food for special medical purposes (Profermin)

Treatment:

Other: Profermin