Ulcerative Colitis
Conditions
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.
Interventions
OTHERProfermin
Medical Food (food for special medical purposes)
Sponsors
Hvidovre University Hospital
Nordisk Rebalance A/S
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed