Study Evaluating the Effect of UCB8600 on Mast Cell Activation in the Human Gut
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Donation of resection material
Collection of colonic resection material of subjects undergoing abdominal surgery due to malignancies
干预措施: Sample collection (Other)
Rectal biopsies
Collection of rectal biopsies of IBS patients
干预措施: Sample collection (Other)
研究者
Guy Boeckxstaens
prof. dr.
KU Leuven