Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)

Seattle Children's Healthcare System

Status: Enrolling

Conditions: Functional Bowel Disorder; Gallbladder Diseases; Gastroduodenal Disorder; Esophageal Diseases; Sphincter of Oddi Dysfunction; Bowel Dysfunction; Anorectal Disorder; Ulcerative Colitis; Functional Abdominal Pain Syndrome; Inflammatory Bowel Diseases; Indeterminate Colitis; Crohn Disease

Treatments: Diagnostic Test: Colonoscopy w/ biopsy; Diagnostic Test: Esophagogastroduodenoscopy (EGD) with biopsy

Study type: Observational

Funder types: Other

Identifiers

NCT06315179

STUDY00004616

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 6 to 21 years old

Volunteers: No Healthy Volunteers

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

Trial design

200 participants in 2 patient groups

Inflammatory Bowel Disease

Description:

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.

Treatment:

Diagnostic Test: Esophagogastroduodenoscopy (EGD) with biopsy

Diagnostic Test: Colonoscopy w/ biopsy

Disorders of the Brain-Gut Interactions

Description:

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.

Treatment:

Diagnostic Test: Esophagogastroduodenoscopy (EGD) with biopsy

Diagnostic Test: Colonoscopy w/ biopsy