Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Bio-repository sample collection for spatial transcriptomics
研究概览
简要总结
This is a prospective observational study collecting long-term clinical data and samples for research in pediatric inflammatory bowel disease (IBD) patients with gut inflammation and a control cohort of pediatric patients with disorders of the brain-gut interactions (DBGI) with no detectable gut inflammation.
详细描述
Research procedures will coincide with clinical visits at institutional standards. As part of their clinical disease evaluation, participants will have blood, stool, and tissue collected as indicated by their disease course. Additional research samples or data will be collected during these visits. Participants will be asked to collect urine samples specifically for research.
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
- 6 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Suspected diagnosis of CD (Crohn's Disease), UC (Ulcerative Colitis) or Indeterminate colitis (IC)
排除标准
- •Evidence of Other Complicating Medical Issues:
- •Other serious medical conditions, such as neurological, liver, kidney, or systemic disease
- •Pregnancy
- •Tobacco, alcohol, or illicit drug abuse
研究组 & 干预措施
Inflammatory Bowel Disease
Participants will enroll before their initial diagnostic procedure. After pathology results are reported, participants will be categorized based on the assigned diagnoses: Inflammatory Bowel Disease (IBD) [Crohn's disease (CD), ulcerative colitis (UC), and Indeterminate Colitis (IC)] vs Disorders of the Brain-Gut Interactions (DGBI).
Participation in the IBD cohort will last for three years.
干预措施: Esophagogastroduodenoscopy (EGD) with biopsy (Diagnostic Test)
Inflammatory Bowel Disease
Participants will enroll before their initial diagnostic procedure. After pathology results are reported, participants will be categorized based on the assigned diagnoses: Inflammatory Bowel Disease (IBD) [Crohn's disease (CD), ulcerative colitis (UC), and Indeterminate Colitis (IC)] vs Disorders of the Brain-Gut Interactions (DGBI).
Participation in the IBD cohort will last for three years.
干预措施: Colonoscopy w/ biopsy (Diagnostic Test)
Disorders of the Brain-Gut Interactions
Participants will enroll before their initial diagnostic procedure. After pathology results are reported, participants will be categorized based on the assigned diagnoses: Inflammatory Bowel Disease (IBD) [Crohn's disease (CD), ulcerative colitis (UC), and Indeterminate Colitis (IC)] vs Disorders of the Brain-Gut Interactions (DGBI).
-The DGBI cohort will be subdivided into: Esophageal Disorder, Gastroduodenal Disorder, Bowel Disorder, Centrally Mediated Disorders of GI Pain, Gallbladder and Sphincter of Oddi Disorder, Anorectal Disorder, Childhood Functional GI Disorders: Neonate/Toddler, Childhood Functional GI Disorders: Child/Adolescent
Participation in the DGBI cohort will include the initial sample and data collection as well an one further medical record extraction at month 24.
干预措施: Esophagogastroduodenoscopy (EGD) with biopsy (Diagnostic Test)
Disorders of the Brain-Gut Interactions
Participants will enroll before their initial diagnostic procedure. After pathology results are reported, participants will be categorized based on the assigned diagnoses: Inflammatory Bowel Disease (IBD) [Crohn's disease (CD), ulcerative colitis (UC), and Indeterminate Colitis (IC)] vs Disorders of the Brain-Gut Interactions (DGBI).
-The DGBI cohort will be subdivided into: Esophageal Disorder, Gastroduodenal Disorder, Bowel Disorder, Centrally Mediated Disorders of GI Pain, Gallbladder and Sphincter of Oddi Disorder, Anorectal Disorder, Childhood Functional GI Disorders: Neonate/Toddler, Childhood Functional GI Disorders: Child/Adolescent
Participation in the DGBI cohort will include the initial sample and data collection as well an one further medical record extraction at month 24.
干预措施: Colonoscopy w/ biopsy (Diagnostic Test)
结局指标
主要结局
Bio-repository sample collection for spatial transcriptomics
时间窗: 3 years
Collection of blood and stool samples at baseline month 1, month 2, month 3, month 6, month 12, month 24, and month 36. Tissue will be collected at baseline and at any follow-up endoscopy or surgical intervention.
次要结局
- Paris Classification of Ulcerative Colitis/Indeterminate Colitis(Baseline)
- Montreal Classification of Ulcerative Colitis/Indeterminate Colitis(Baseline)
- Physician's Global Assessment (PGA)(3 years)
- Montreal Classification of Crohn's disease(Baseline)
- Paris Classification of Crohn's Disease(Baseline)
- Disorder of Gut-Brain Interaction classification(Baseline)
研究者
Betty Zheng
Assistant Professor, Director of Advanced IBD Fellowship Program
Seattle Children's Hospital