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_TEST
    Esophagogastroduodenoscopy (EGD) is a test procedure to examine the lining of the esophagus, stomach, and first part of the small intestine.
  • Colonoscopy w/ biopsy — DIAGNOSTIC_TEST
    Colonoscopy 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 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.
  • Arm: 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.

Primary Outcome Measure

Bio-repository sample collection for spatial transcriptomics [ Time Frame: 3 years ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Seattle Children's HospitalSeattleWashington98105
Mason E Nuding
206-987-0055
Clinical Research Coordinator
206-987-2521
Hengqi Zheng, MD (PRINCIPAL_INVESTIGATOR)

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