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Casein glycomacropeptide (CGMP) has anti-inflammatory properties in experimental rodent colitis and using human in vitro inflammation models. Its use as a food ingredient has proven safe and with no influence on dietary intake. In a pilot study the investigators found, that orally administered CGMP seems to have a beneficial effect comparable to that of mesalazine in active distal ulcerative colitis.
The investigators wish to evaluate the effects in a larger group of patients with active ulcerative colitis by studying the clinical effects and assessing the anti-inflammatory and microbiome modulating properties.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Casein glycomacropeptide (CGMP) | Active Comparator | As add-on to the standard medical treatment of active ulcerative colitis the patients will receive a daily oral intake of CGMP-protein-shake during 12 weeks. |
|
| Placebo | Placebo Comparator | As add-on to the standard medical treatment of active ulcerative colitis the patients will receive a daily oral intake of placebo-shake consisting of milk powder during 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Casein glycomacropeptide (CGMP) | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic remission | The number of patients in endoscopic remission/macroscopic mucosal healing (Endoscopic Mayo Score of 0) | 12 weeks |
| Clinical remission | The number of patients in clinical remission (SCCAI ≤ 2) | 12 weeks |
| Clinical Response | The number of patients with clinical response (reduction of SCCAI-score of at least 2 points) | 12 weeks |
| Fecal inflammatory marker | The number of patients with a fecal-calprotectin below 150 mg/kg | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endoscopic response | The number of patients with endoscopic response (reduction of Endoscopic Mayo Score of at least 1point) | 12 weeks |
| Steroid-free remission | The number of patients in steroid-free remission (SCCAI ≤ 2) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hendrik A Vilstrup, Professor | University of Aarhus | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of medicine V (Hepatology and Gastroenterology) | Aarhus C | 8000 | Denmark |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| Dietary Supplement |
|
| 12 weeks |
| Clinical remission at follow-up | The number of patients in clinical remission (SCCAI ≤ 2) | 26 weeks |
| D003108 |
| Colonic Diseases |
| D007410 | Intestinal Diseases |