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

NCT06315179 | Recruiting

• 1 other identifier: STUDY00004616
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

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

Keywords

IBD; DGBI

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Paris Classification of Crohn's Disease

  Baseline

• Montreal Classification of Crohn's disease

  Baseline

• Paris Classification of Ulcerative Colitis/Indeterminate Colitis

  Baseline

• Montreal Classification of Ulcerative Colitis/Indeterminate Colitis

  Baseline

• Disorder of Gut-Brain Interaction classification

  Baseline

Study Arms (2)

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; Diagnostic Test: Colonoscopy w/ biopsy

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; Diagnostic Test: Colonoscopy w/ biopsy

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.

Disorders of the Brain-Gut Interactions; Inflammatory Bowel Disease

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.

Disorders of the Brain-Gut Interactions; Inflammatory Bowel Disease

Eligibility Criteria

• Age: 6 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

All individuals who meet inclusion criteria will be approached.

You may qualify if:

• Suspected diagnosis of CD (Crohn's Disease), UC (Ulcerative Colitis) or Indeterminate colitis (IC)

You may not qualify if:

• 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

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• Allen Institute: collaborator

Study Sites (1)

Seattle Children's Hospital

Seattle, Washington, 98105, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

-The blood and tissue bio-specimens obtained for this research will undergo genetic testing including but not limited to single-cell analysis, exome sequencing, and whole genome sequencing, gene editing, and organoid generation (results will not be provided to participants and/or their care providers). Cells are not 'immortalized' and will eventually expire.

MeSH Terms

Conditions

Inflammatory Bowel Diseases; Crohn Disease; Colitis, Ulcerative; Esophageal Diseases; Intestinal Diseases; Gallbladder Diseases; Sphincter of Oddi Dysfunction; Rectal Diseases

Interventions

Endoscopy, Digestive System; Biopsy

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Colitis; Colonic Diseases; Biliary Tract Diseases; Biliary Dyskinesia; Common Bile Duct Diseases; Bile Duct Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, Digestive System; Diagnostic Techniques and Procedures; Diagnosis; Endoscopy; Diagnostic Techniques, Surgical; Digestive System Surgical Procedures; Surgical Procedures, Operative; Minimally Invasive Surgical Procedures; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Specimen Handling; Investigative Techniques

Study Officials

• Betty (Hengqi) Zheng, MD

  Seattle Children's Hospital, University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mason E Nuding, BS

CONTACT

206-987-0055; mason.nuding@seattlechildrens.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Director of Advanced IBD Fellowship Program

Study Record Dates

• First Submitted: March 5, 2024
• First Posted: March 18, 2024
• Study Start: May 10, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)