Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Hvidovre University Hospital | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study aim to investigate the effect of Profermin versus Fresubin in the dietetic treatment of active ulcerative colitis.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Profermin | Experimental |
| |
| Fresubin | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Profermin | Other | Medical Food (food for special medical purposes) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Development in Simple Clinical Colitis Activity Index (SCCAI) score | Clinical significant difference (>1.5) in course of SCCAI score between the two intervention groups | 8 and 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in SCCAI score | Proportion of patients with a reduction in SCCAI above 1.5, 3.0 and 4.5 | 8 and 16 weeks |
| Clinical remission | Proportion of patients in clinical remission (SCCAI=<2.5) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Hans Israelsen, PhD | Nordisk Rebalance A/S | Study Director |
| Aleksander Krag, MD, PhD | Hvidovre University Hospital | Principal Investigator |
| Flemming Bendtsen, MD, DMSci | Hvidovre University Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noreba | Allerød Municipality | Capital Region | 3450 | Denmark |
Not provided
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C574856 | profermin |
| C048418 | Fresubin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Fresubin |
| Other |
Medical food (food for special medical purposes) |
|
| 8 and 16 weeks |
| Safety - Number of Participants with Adverse Events as a Measure of Safety and Tolerability | 20 weeks |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |