Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)
Purpose
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.
Conditions
- Inflammatory Bowel Diseases
- Crohn Disease
- Ulcerative Colitis
- Indeterminate Colitis
- Functional Abdominal Pain Syndrome
- Functional Bowel Disorder
- Esophageal Diseases
- Gastroduodenal Disorder
- Bowel Dysfunction
- Gallbladder Diseases
- Sphincter of Oddi Dysfunction
- Anorectal Disorder
Eligibility
- Eligible Ages
- Between 6 Years and 21 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Suspected diagnosis of CD (Crohn's Disease), UC (Ulcerative Colitis) or Indeterminate colitis (IC)
Exclusion Criteria
- 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
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
| 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. |
|
Recruiting Locations
Seattle Children's Hospital
Seattle, Washington 98105
Seattle, Washington 98105
More Details
- NCT ID
- NCT06315179
- Status
- Recruiting
- Sponsor
- Seattle Children's Hospital
Detailed Description
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.