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NCT Number: NCT06315179

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

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.

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Key information

Conditions

Inflammatory Bowel Diseases Anorectal Disorder Bile Duct Diseases Biliary Dyskinesia Biliary Tract Diseases Bowel Dysfunction Colitis Colitis, Ulcerative Colonic Diseases Common Bile Duct Diseases Crohn Disease Digestive System Diseases Esophageal Diseases Functional Abdominal Pain Syndrome Functional Bowel Disorder Gallbladder Diseases Gastroduodenal Disorder Gastroenteritis Gastrointestinal Diseases Indeterminate Colitis Intestinal Diseases Rectal Diseases Sphincter of Oddi Dysfunction Ulcerative Colitis

Age range

6 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Bio-repository sample collection for spatial transcriptomics

    Time frame: 3 years

    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.

Secondary outcomes

  1. Paris Classification of Crohn's Disease

    Time frame: Baseline

    • 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

  2. Montreal Classification of Crohn's disease

    Time frame: Baseline

    • 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

  3. Paris Classification of Ulcerative Colitis/Indeterminate Colitis

    Time frame: Baseline

    • 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

  4. Montreal Classification of Ulcerative Colitis/Indeterminate Colitis

    Time frame: Baseline

    • 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

  5. Disorder of Gut-Brain Interaction classification

    Time frame: Baseline

    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

  6. Physician's Global Assessment (PGA)

    Time frame: 3 years

    Severity: Quiescent, Mild, Moderate, Severe

Study contacts

Contact information is provided by the study sponsor or research team.

Mason E Nuding, BS

CONTACT

[email protected]

206-987-0055

Sponsors and collaborators

Lead sponsor

Seattle Children's Hospital

Other

Collaborators

  • Allen Institute

Registry information

Official study title

Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation

Acronym: STRIDE

Important dates

Study start
2024
Primary completion
2028
Study completion
2030
First posted
Mar 18, 2024
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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