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| Name | Class |
|---|---|
| UCB S.A. - Pharma Sector | INDUSTRY |
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Study evaluating the effect of UCB8600 on mast cell activation in the human gut:
IBS is a disease characterized by abdominal pain and a change in stool. Treatment is limited to an adapted life style, dietary changes and medication to lessen cramps (spasmolytica), all of which have seen limited to no clinical success.
Recently, we were able to demonstrate that mast cells play an active role in IBS symptoms. More specifically, they set histamine free when activated which heightens nerve sensitivity in the intestines which probably contributes to the abdominal pain. A new product called "UCB8600" is hypothesized to be able to counteract this by causing less mast cells to be activated. In this study we'll test this by administering UCB8600 on intestinal tissue and see if there is less mast cell activation. If the study produces good results, this new product could potentially be used as a treatment for IBS in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Donation of resection material | Other | Collection of colonic resection material of subjects undergoing abdominal surgery due to malignancies |
|
| Rectal biopsies | Other | Collection of rectal biopsies of IBS patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sample collection | Other | Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total percentage of degranulated mast cells, detected using fluorescence microscopy | Using an avidin essay and fluorescence microscopy, the percentage of degranulated mast cells will be quantified | After finishing the essay, approximately on day 2 |
| Total corrected cellular fluorescence (TCCF) per mast cell | Using an avidin essay and fluorescence microscopy, the TCCF per mast cell will be quantified | After finishing the essay, approximately on day 2 |
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Inclusion Criteria group 1 (resection tissue from surgery patients = healthy volunteers):
Exclusion Criteria group 1 (resection tissue from surgery patients = healthy volunteers):
Inclusion Criteria group 2 (rectal biopsies from IBS patients):
Exclusion Criteria group 2 (rectal biopsies from IBS patients):
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ine De Booser, MSc | Contact | 0032-16-341943 | ine.debooser@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Guy Boecxkstaens, prof. dr. | Catholic University Leuven and Universitary Hospitals Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Leuven | Leuven | Vlaams-Brabant | 3000 | Belgium |
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| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
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| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| ID | Term |
|---|---|
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D008919 | Investigative Techniques |
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| D004066 | Digestive System Diseases |