Seroprevalence of Anti-bodies Against Clostridium Difficile Toxins and Prevalence of Asymptomatic Carriage of Clostridium Difficile in IBD Patients.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Prevalence of Clostridium difficile anti-toxin Abs in patients with IBD
研究概览
简要总结
The objective of this study to evaluate the seroprevalence of anti-bodies against C. difficile toxins A and B and the asymptomatic carriage of C. difficile in IBD patients according to the need and type of immunosuppressive therapy. The ultimate goal is to identify, among IBD patients, those with the highest risk of CDI.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
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
- •Signed informed consent
- •Diagnosed of IBD, either Crohn's disease or ulcerative colitis
- •Age: >18 and <65 years
- •Time since diagnoses of IBD ≥ 6 months
- •Present with the criteria included in any of the 4 specified groups in the study population
排除标准
- •History of documented CDI
- •Active CDI at the moment of study inclusion
- •Any of the following immunosuppressive conditions: HIV infection, Liver cirrhosis, CKD stage IV, Receiving chemotherapy, Transplant (solid organ or hematological), Concomitant neoplasia, Hypogammaglobinemia.
结局指标
主要结局
Prevalence of Clostridium difficile anti-toxin Abs in patients with IBD
时间窗: 0 days
Determination of serum anti-toxin Abs for C. difficile with ELISA (enzyme-linked immunosorbent assay). The concentration of C. difficile anti-toxin Abs will be categorized as: \< 25 percentile: Low, \>26 \< 75 percentiles: Intermediate, \>76 \<90 percentiles: High, \>91 percentile: Very high.
Prevalence of asymptomatic carrier of Clostridium difficile in patients with IBD
时间窗: 0 days
Stool testing for C. difficile as part of a multiple step algorithm: GDH (glutamate dehydrogenase), toxin EIA (enzyme immunoassay) test and C. difficile culture.
Study the relationship between the different maintenance therapies for IBD and C. difficile anti-toxin Abs and asymptomatic carriers.
时间窗: 0 days
次要结局
未报告次要终点
研究者
Claudia Arajol Gonzalez
Principal Investigator
Hospital Universitari de Bellvitge