Study Evaluating the Effect of UCB8600 on Mast Cell Activation in the Human Gut (MASTGUT)
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.
研究概览
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名:Ine De Booser, MSc
- 电话号码:0032-16-341943
- 邮箱:ine.debooser@uzleuven.be
学习地点
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Vlaams-Brabant
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Leuven、Vlaams-Brabant、比利时、3000
- 招聘中
- University Hospitals Leuven
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接触:
- Ine De Booser, MSc
- 电话号码:0032-16-341943
- 邮箱:ine.debooser@uzleuven.be
-
-
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria group 1 (resection tissue from surgery patients = healthy volunteers):
- Voluntary written informed consent of the participant has been obtained prior to any screening procedures
- At least 18 years of age at the time of signing the Informed Consent Form (ICF)
- Undergoing surgery for colorectal cancer
- No preoperative radiotherapy or chemotherapy
Exclusion Criteria group 1 (resection tissue from surgery patients = healthy volunteers):
- Using antihistamines such as ebastine, cetirizine, desloratadine, … (non-exhautive list) at the moment of surgery
- Inflammatory bowel disease (IBD) or diverticulitis
- Diabetes or BMI ≥ 30 kg/m²
- Subject is legally incapacitated
Inclusion Criteria group 2 (rectal biopsies from IBS patients):
- Voluntary written informed consent of the subject has been obtained prior to any screening procedures
- At least 18 years of age and maximum age of 65 years of age at the time of signing the Informed Consent Form (ICF)
- Diagnosed with IBS
Exclusion Criteria group 2 (rectal biopsies from IBS patients):
- Subject has internal/external hemorrhoids at the moment of biopsy sampling.
- Using bloodthinners such as Acenocoumarol, Aspirine (acetylsalicylzuur), Apixaban (Eliquis), Clopidogrel (Plavix), Dabigatran (Pradaxa), Edoxaban (Lixiana), Rivaroxaban (Xarelto), warfarine (Marevan®) and Enoxaparine (Clexane), … (non-exhausative list).
- Using antihistamines such as ebastine, cetirizine, desloratadine, … (non-exhausative list) at the moment of biopsy sampling. These should be stopped 2 weeks prior to the biopsy sampling.
- Subject is legally incapacitated
学习计划
研究是如何设计的?
设计细节
- 主要用途:其他
- 分配:非随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他:Donation of resection material
Collection of colonic resection material of subjects undergoing abdominal surgery due to malignancies
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Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)
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其他:Rectal biopsies
Collection of rectal biopsies of IBS patients
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Collection of colonic resection material (surgery patients) and rectal biopsies (IBS patients)
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Total percentage of degranulated mast cells, detected using fluorescence microscopy
大体时间:After finishing the essay, approximately on day 2
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Using an avidin essay and fluorescence microscopy, the percentage of degranulated mast cells will be quantified
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After finishing the essay, approximately on day 2
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Total corrected cellular fluorescence (TCCF) per mast cell
大体时间:After finishing the essay, approximately on day 2
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Using an avidin essay and fluorescence microscopy, the TCCF per mast cell will be quantified
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After finishing the essay, approximately on day 2
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合作者和调查者
调查人员
- 首席研究员:Guy Boecxkstaens, prof. dr.、Catholic University Leuven and Universitary Hospitals Leuven
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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