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| ID | Type | Description | Link |
|---|---|---|---|
| EC - L71/2003 | |||
| BFARM - 402 29 17 |
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| Name | Class |
|---|---|
| Professor Wolfgang Stremmel | UNKNOWN |
| Dietmar Hopp Stiftung | OTHER |
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The purpose of this study is to evaluate if retarded release phosphatidylcholine is an effective alternative to steroid dependent or -refractory course in chronic active ulcerative colitis.
The hypothesis is, that ulcerative colitis is caused by a barrier defect of the colonic mucus layer. The background of the study is the finding, that the phosophatidylcholine content of the colonic mucus is strongly reduced in ulcerative colitis (UC) compared to healthy controls and patients with Crohn´s disease. The content was measured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method for steroid dependent UC. See: Gut. 2005 Jul;54(7):966-71. Stremmel et al.
Design: Prospective, randomized, placebo-controlled, double-blinded study.
Population: 60 patients with chronic active ulcerative colitis and steroid dependency
Inclusion: Chronic active ulcerative colitis, clinical index 5 or more, endoscopic Index 5 or more, steroid dependent course since at least 4 months.
Main criteria: complete steroid reduction
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Retarded Release Phosphatidylcholine (rPC) | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| complete steroid reduction |
| Measure | Description | Time Frame |
|---|---|---|
| remission, life quality, clinical indices, endoscopic indices, histological score, subgroup analysis |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Wolfgang Stremmel, Professor | Heidelberg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Heidelberg - Medical Department 4 - Gastroenterology | Heidelberg | 69120 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15951544 | Background | Stremmel W, Merle U, Zahn A, Autschbach F, Hinz U, Ehehalt R. Retarded release phosphatidylcholine benefits patients with chronic active ulcerative colitis. Gut. 2005 Jul;54(7):966-71. doi: 10.1136/gut.2004.052316. | |
| 17975182 | Derived | Stremmel W, Ehehalt R, Autschbach F, Karner M. Phosphatidylcholine for steroid-refractory chronic ulcerative colitis: a randomized trial. Ann Intern Med. 2007 Nov 6;147(9):603-10. doi: 10.7326/0003-4819-147-9-200711060-00004. |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |