Setting up a Cohort of Patients With Inflammatory Bowel Disease and a Cohort of Patients Without Chronic Inflammatory Bowel Disease in the Context of the Translational Study of Biomarkers of Intestinal Dysbiosis (ELITE Walloon Project)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Artialis
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of patients recruited in each cohort
研究概览
简要总结
The objective of this study is to constitute cohorts of IBD versus non-IBD patients to identify (a) new biomarker(s) of intestinal dysbiosis associated with inflammatory bowel disease, and develop a prototype for assaying such marker(s) in blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •General criteria:
- •Male or female ≥ 18 years old
- •Able to follow the instructions of the study
- •Having signed an informed consent
- •Specific for Crohn cohort:
- •A confirmed diagnosis of IBD
- •Rectal or colonic or ileocolic involvement
- •Patients with CD presenting inflammatory flare and disease extent in the colon or ileocolic region with:
- •A clinical activity defined by an average of four or more instances of very soft or liquid stools daily or an abdominal pain score of 2 or more OR a CDAI (CD Activity Index) ≥ 220 OR a Harvey-Bradshaw Index > 8 OR a faecal calprotectin ≥ 250 µg/g And
- •A endoscopic activity defined by a SES-CD (Simple Endoscopic Score for Crohn Disease) ≥ 6 or a CDEIS (CD Endoscopic Index score) ≥ 7
- •Patients with UC presenting inflammatory flare with:
- •A clinical activity defined by a modified Mayo score ≥ 3 OR a Simple Clinical Colitis Activity Index ≥5 OR Patient Reported Outcome (PRO2) ≥ 4 with a subscore of rectal bleeding ≥1 OR a faecal calprotectin ≥ 250 µg/g AND An endoscopic activity defined by a Mayo endoscopic sub-score ≥ 2
- •Specific for Control cohort:
- •Patient with no colonic lesion(s) visible during the endoscopical examination (neither Crohn's nor other colitis nor cancer)
排除标准
- •General criteria:
- •Commercial Pharmaceutical probiotic administration within the previous month
- •Treatment with antibiotics (whatever the route of administration) within last 3 months
- •Non-remission Cancer or in remission for less than 6 months
- •Any contraindication to colonoscopy and/or biopsy, left to PI discretion
- •Under guardianship or judiciable protection
- •Pregnant or breastfeeding women
- •Currently participating or having participated in the last 3 months to a clinical study with investigational medicine or food supplement
- •Specific for Crohn cohort:
- •Crohn disease localized only in Ileum
- •Inflammatory colon pathology other than Crohn's (infectious, drug-induced,…)
研究组 & 干预措施
Inflammatory bowel disease cohort
60 patients diagnosed with colonic inflammatory bowel disease
干预措施: biological samples collection (Procedure)
Control cohort
60 control patients without inflammatory bowel diseases
干预措施: biological samples collection (Procedure)
结局指标
主要结局
Number of patients recruited in each cohort
时间窗: 27 months
60 patients in IBD cohort and 60 patients in control cohort
number of faeces samples collected in each cohort
时间窗: 27 months
60 patients in IBD cohort and 60 patients in control cohort
Number of plasma samples collected in each cohort
时间窗: 27 months
60 patients in IBD cohort and 60 patients in control cohort
Number of biopsy samples collected in each cohort
时间窗: 27 months
60 patients in IBD cohort and 60 patients in control cohort with 4 colonic biopsies/ patient
次要结局
未报告次要终点