SNU IBD Cohort Study : Searching for Characterization of High Risk Populations for Developing Inflammatory Bowel Disease (SNU PREVENT)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Incidence of Inflammatory Bowel Disease
研究概览
简要总结
The goal of this observational study is to investigate characteristics of individuals at high risk for developing Inflammatory Bowel Disease (IBD) in order to identify risk factors associated with its incidence.
The main question it aims to answer is:
What are the risk factors for developing Inflammatory Bowel Disease?
Researchers will compare groups at high risk for IBD to healthy populations and to patients already diagnosed with IBD.
Participants will
- undergo assessments of general demographic and clinical characteristics.
- be monitored for symptoms using questionnaires administered at regular intervals.
- have blood tests and stool examinations performed. In cases where participants undergo colonoscopy for routine clinical indications, gut biopsies will also be performed.
详细描述
Recruitment announcements for participants who are first-degree relatives with patients of IBD will be posted on the bulletin board of the patient community, the outpatient bulletin board, and in the consultation room. For patients with confirmed Anti-Saccharomyces cerevisiae antibody (ASCA) positivity or those diagnosed with autoimmune diseases, recruitment will be conducted from among outpatients who meet the criteria. Detailed explanations about the study will be provided, and consent to participate will be obtained prior to recruitment.
Blood and stools will be used for genomic and proteomic, metabolomic analysis. 16s rRNA gene sequencing and whole genome shotgun sequencing will be done for microbiome analysis. Biopsy specimen will be used for proteomic analysis.
Adverse events related with blood sampling will be monitored in outpatient clinic.
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
- 10 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •first-degree relatives of Inflammatory Bowel Disease patients
- •patients who are diagnosed with autoimmune diseases
- •patients with functional gastrointestinal disorders who are ASCA-positive
排除标准
- •Patients with symptoms such as a 10% weight loss within 3 months, abdominal pain, hematochezia, or diarrhea will undergo colonoscopy, and those diagnosed with Inflammatory Bowel Disease will be excluded.
- •Treatment history of Diabetes Mellitus, Irritable Bowel Syndrome, or colon cancer.
结局指标
主要结局
Incidence of Inflammatory Bowel Disease
时间窗: Up to 20 years from enrollment
次要结局
未报告次要终点
研究者
SeongJoon Koh
Associate Professor
Seoul National University Hospital