Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)
Part of paid clinical trials in Seattle, Washington.
- Sponsor
- Seattle Children's Hospital
- Study ID
- NCT06315179
- Status
- Recruiting
Conditions
- Anorectal Disorder
- Bowel Dysfunction
- Crohn Disease
- Esophageal Diseases
- Functional Abdominal Pain Syndrome
- Functional Bowel Disorder
- Gallbladder Diseases
- Gastroduodenal Disorder
- Indeterminate Colitis
- Inflammatory Bowel Diseases
- Sphincter of Oddi Dysfunction
- Ulcerative Colitis
Eligibility Criteria
- Sex
- ALL
- Age
- 6 Years - 21 Years
- Healthy Volunteers
- Not accepted
Interventions
- Esophagogastroduodenoscopy (EGD) with biopsy — DIAGNOSTIC_TESTEsophagogastroduodenoscopy (EGD) is a test procedure to examine the lining of the esophagus, stomach, and first part of the small intestine.
- Colonoscopy w/ biopsy — DIAGNOSTIC_TESTColonoscopy is a test procedure to examine the lining of the different portions of the large intestine: cecum, colon, rectum, and anal canal.
Study Details
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.
Key Dates
- Start date
- May 10, 2024
- Status verified
- Apr 2026
- Primary completion
- Jan 31, 2028
- Completion
- Jan 31, 2030
Study Design
- Enrollment
- 200 participants (estimated)
Arms
- Arm: Inflammatory Bowel DiseaseParticipants 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.
- Arm: Disorders of the Brain-Gut InteractionsParticipants 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.
Primary Outcome Measure
Bio-repository sample collection for spatial transcriptomics [ Time Frame: 3 years ]
Central Contacts
- Mason E Nuding, BS206-987-0055
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Seattle Children's Hospital | Seattle | Washington | 98105 | Hengqi Zheng, MD (PRINCIPAL_INVESTIGATOR) |
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