Blood and Stool Molecular Biomarkers Longitudinal Detection Study in Crohn's Disease (CD) Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 41
- 试验地点
- 10
- 主要终点
- Assess disease status biomarkers against colonoscopy
研究概览
简要总结
To evaluate the relationship between noninvasive biomarkers (patient serological markers and metagenomic analysis of stool) and disease status as determined by colonoscopy and by clinical symptoms in patients with Crohn's disease, and to evaluate whether changes in the biomarker levels over time correlate to changes in the state of patients' disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females with CD who are 18 years of age or older on the date of obtaining informed consent and are undergoing a colonoscopy at the study site.
- •The patient must have a confirmed diagnosis of CD based on results a complete medical evaluation and the assessment by a physician specialized in inflammatory bowel disease.
- •All CD patients should have no evidence for another active organic disease of the GI tract or medical problems as specified below in the
排除标准
- •All patients must have a colonoscopic examination performed preferably on the same day as blood specimen is drawn, or blood may be drawn up to one week prior to colonoscopy. Stool specimen will be collected prior to the beginning of bowel prep for the colonoscopy, up to 10 days prior to bowel prep.
- •Understand the procedures and requirements of the study by providing written informed consent including consent and authorization for protected health information disclosure.
- •Exclusion Criteria:
- •Extensive small bowel resection or short bowel syndrome.
- •Surgery for CD within the 6 months previous to enrollment.
- •Receipt of any blood products within 3 months prior to study entry.
- •Known pregnancy or breast feeding within 3 months of specimen collection.
- •Recent history of viral or bacterial gastroenteritis including Clostridium difficile infection < 4 weeks prior to the blood draw
- •Concurrent diagnosis of another currently active erosive GI mucosal disease such as erosive esophagitis, gastric or duodenal ulcer, celiac sprue, diverticulitis, etc.
- •History of intestinal or colorectal cancer, of active autoimmune diseases, or of other chronic uncontrolled systemic disorders
- •History of bowel prep within the past 3 months.
- •History of alcohol or substance abuse.
- •History of prior colectomy or stricturing disease that could limit colonoscopy examination of small bowel mucosa.
- •Current ostomy or ileoanal pouch.
- •Current or previous (of less than 4 weeks prior) participation in in a clinical trial for an investigational drug.
研究组 & 干预措施
Single Group
This is a prospective, longitudinal descriptive study of subjects with diagnosed Crohn's disease. Blood samples for measurement of protein biomarkers (serology), fresh whole blood for detection of gene polymorphisms, and stool samples for detection and assessment of microbiome and host DNA will be collected, and colonoscopy will be performed.
干预措施: Colonoscopy (Procedure)
结局指标
主要结局
Assess disease status biomarkers against colonoscopy
时间窗: 6 months
The primary endpoint for assessing clinical validity of candidate biomarker will be correlation to the degree of mucosal healing as determined by colonoscopy scored by the Simple Endoscopic Score for Crohn's Disease (SES-CD). - A scale that via colonoscopy of Crohn's disease patients measures: 1. Presence and size of ulcers 2. Extent of ulcerated surface 3. Extent of affected surface and 4. Presence and type of intestinal narrowings. Scale goes from 0 to 56 with a higher score indicating greater severity of disease.
次要结局
- Assess bacterial markers in stool against colonoscopy scoring system Simple Endoscopic Score for Crohn's Disease (SES-CD)(6 months)
- Assess bacterial markers in stool against colonoscopy scoring system Crohn's Disease Endoscopic Index of Severity (CDEIS)(6 months)
- Assess bacterial markers in stool against disease symptomology scored by Harvey Bradshaw Index (HBI) for clinical evaluation(6 months)
- Assess bacterial markers in stool against disease symptomology scored by Crohn's Disease Activity Index (CDAI) for clinical evaluation(6 months)