The Contact Activation System and Ulcerative Colitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Clinical disease activity.
研究概览
简要总结
The study aims to describe alterations in the contact activation system during active and inactive ulcerative colitis.
Contact activation system measures are compared in a cross sectional (healthy controls vs. active disease) and longitudinal (active diasese vs. inactive disease) fashion.
详细描述
We include and follow up on 102 adults with active ulcerative colitis. Visits are week 0 (inclusion), 6, 12 and 26 (end of study). We obtain plasma and fecal samples at each visit. Whereas we obtain colonic tissue samples only at inclusion and end of study.
Registered data are:
- Demographics realate to UC and general wellbeing.
- Clinical parametres used for UC evaluation are PRO2, SCCAI, CRP, fecal calprotectin, Mayo endoscopic subscore and Nancy index.
- The contact activation system is characterised by FXII, prekallikrein, kallikrein generation, HK, cHK (specific to plasma kallikrein), cHK (specific to tissue kallikrein), C1 inhibitor and Kallistatin.
- Polymerized alpha-1-antitrypsin is characterised by the degree of polymerization and the capacity to activate the contact activation system.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fulfill diagnostic criteria of ulcerative colitis
- •SCCAI score ≥ 5
- •Mayo Endoscopic Subscore ≥ 1
- •Age ≥ 18 years
- •Most understand written and oral information in Danish
- •Informed consent must be given
排除标准
- •Pregnancy
- •Infection at inclusion
- •Any existing disease at inclusion:
- •liver disease or defect in CAS
- •inflammatory rheumatologic or dermatologic disease
- •cardiovascular or renal disease
- •immunodeficiency or hematologic diseases
- •malignancies
- •Medication with
- •Systemic corticosteroids at inclusion
- •ACE-inhibitor
- •Acetylsalicylic acid/NSAID
- •Warfarin, Phenprocoumon, NOAC and heparins
结局指标
主要结局
Clinical disease activity.
时间窗: End of study (August 28th, 2024)
PRO2 score, 0-6 points. A score of one or more defines active disease.
Polymerised alpha-1-antitrypsin in participants
时间窗: End of study (August 28th, 2024)
A Western blot verifies the present of polymerised alpha-1-antitrypsin.
Localisation of contact activation system components in tissue samples
时间窗: End of study (August 28th, 2024)
Immunhistochemical methods locate FXII, PK, cHK (specific to plasma kallikrein and tissue kallikrein), C1 Inhibitor, and Kallistatin in biopsies.
Endoscopic disease activity.
时间窗: End of study (August 28th, 2024)
Mayo endoscopic score, 0-3 points. A score of one or more defines active disease.
Kallikrein generation
时间窗: End of study (August 28th, 2024)
The assay reflects the downstream activation of the contact activation system which allows us to determine the amount of kallikrein generated in each sample.
Polymerised alpha-1-antitrypsin as an activator of the contact activation system
时间窗: End of study (August 28th, 2024)
We add polymerised alpha-1-antitrypsin to our kallikrein generation. If kallikrein is generated the polymers activated the system.
次要结局
未报告次要终点
研究者
Morten Lee Halling
Principal Investigator
Esbjerg Hospital - University Hospital of Southern Denmark