Profermin® in Active Ulcerative Colitis
- Conditions
- Ulcerative Colitis
- Interventions
- Other: Profermin
- Registration Number
- NCT01245465
- Lead Sponsor
- Nordisk Rebalance A/S
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
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.
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-
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Profermin Profermin Daily oral intake of a food for special medical purposes (Profermin)
- Primary Outcome Measures
Name Time Method Our primary endpoint was to estimate the proportion of patients with a reduction in SCCAI ≥50%. 24 weeks Daily report of SCCAI symptoms on the Internet
- Secondary Outcome Measures
Name Time Method Our secondary endpoint was to estimate the proportion of patients in remission defined as SCCAI lower than or equal to 2.5 24 weeks Daily report of SCCAI symptoms on the Internet