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

Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammatory Bowel Diseases; Esophageal Diseases; Gallbladder Diseases; Crohn Disease; Ulcerative Colitis; Sphincter of Oddi Dysfunction; Anorectal Disorder; Bowel Dysfunction; Indeterminate Colitis; Functional Abdominal Pain Syndrome; Functional Bowel Disorder; Gastroduodenal Disorder
• Intervention / Treatment: Diagnostic test: Esophagogastroduodenoscopy (EGD) with biopsy; Diagnostic test: Colonoscopy w/ biopsy

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Mason E Nuding, BS; Phone Number: 206-987-0055; Email: mason.nuding@seattlechildrens.org

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98105
      • Recruiting
      • Seattle Children's Hospital
      • Principal Investigator: Hengqi Zheng, MD
      • Contact: Mason E Nuding; Phone Number: 206-987-0055; Email: mason.nuding@seattlechildrens.org
      • Contact: Clinical Research Coordinator; Phone Number: 206-987-2521; Email: giresearch@seattlechidlrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All individuals who meet inclusion criteria will be approached.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Diagnostic test: Esophagogastroduodenoscopy (EGD) with biopsy; Esophagogastroduodenoscopy (EGD) is a test procedure to examine the lining of the esophagus, stomach, and first part of the small intestine.; Diagnostic test: Colonoscopy w/ biopsy; Colonoscopy is a test procedure to examine the lining of the different portions of the large intestine: cecum, colon, rectum, and anal canal.
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.	Diagnostic test: Esophagogastroduodenoscopy (EGD) with biopsy; Esophagogastroduodenoscopy (EGD) is a test procedure to examine the lining of the esophagus, stomach, and first part of the small intestine.; Diagnostic test: Colonoscopy w/ biopsy; Colonoscopy is a test procedure to examine the lining of the different portions of the large intestine: cecum, colon, rectum, and anal canal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bio-repository sample collection for spatial transcriptomics	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.	3 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Paris Classification of Crohn's Disease	Age at diagnosis; Location of disease: distal 1/3 +- ileum limited cecal disease, colonic, ileocolonic, upper disease proximal to ligament of treitz, upper disease distal to ligament of treitz and proximal to distal 1/3 ileum; Behavior of disease: non-stricturing/non-penetrating, stricturing, penetrating, both penetrating and stricturing disease, either at the same or different times; Perianal sub type: yes, no, do not know; Growth sub type: no evidence of growth delay, growth delay	Baseline
Montreal Classification of Crohn's disease	Age at diagnosis; Location of disease: terminal ileal +- limited cecal disease, colonic, ileocolonic, isolated upper disease; Behavior of disease: non-stricturing/non-penetrating, stricturing, penetrating, both penetrating and stricturing disease, either at the same or different times	Baseline
Paris Classification of Ulcerative Colitis/Indeterminate Colitis	Extent of disease: ulcerative proctitis, left-sided UC (distal to splenic flexure), extensive (hepatic flexure distally), pancolitis (proximal to hepatic flexure); Severity: never severe, ever severe	Baseline
Montreal Classification of Ulcerative Colitis/Indeterminate Colitis	Extent of disease: ulcerative proctitis, left-sided UC (distal to splenic flexure), extensive (proximal to splenic flexure); Severity: clinical remission, mild UC, moderate UC, severe UC	Baseline
Disorder of Gut-Brain Interaction classification	Diagnoses super-type and applicable sub type: Esophageal Disorders; 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	Baseline
Physician's Global Assessment (PGA)	Severity: Quiescent, Mild, Moderate, Severe	3 years

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: Allen Institute
• Investigators: Principal Investigator: Betty (Hengqi) Zheng, MD, Seattle Children's Hospital, University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 11, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 21, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: IBD; DGBI
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Biliary Tract Diseases; Colonic Diseases; Gastroenteritis; Bile Duct Diseases; Colitis; Biliary Dyskinesia; Common Bile Duct Diseases; Colitis, Ulcerative; Crohn Disease; Intestinal Diseases; Gallbladder Diseases; Inflammatory Bowel Diseases; Sphincter of Oddi Dysfunction; Esophageal Diseases; Rectal Diseases; Investigative Techniques; Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytological Techniques; Cytodiagnosis; Diagnostic Techniques, Surgical; Diagnostic Techniques, Digestive System; Endoscopy; Digestive System Surgical Procedures; Biopsy; Endoscopy, Digestive System
• Other Study ID Numbers: STUDY00004616

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No