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Recruiting NCT06315179

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

— Observational Inflammatory Bowel Diseases Crohn Disease Ulcerative Colitis Indeterminate Colitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Esophagogastroduodenoscopy (EGD) with biopsy, Colonoscopy w/ biopsy.
Who it may be relevant to
Registry conditions: Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Indeterminate Colitis. Basic parameters: 6 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation

Overview

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.

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.

Interventions

  • 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.

Primary outcome measures

  • Bio-repository sample collection for spatial transcriptomics [Time frame: 3 years]
Secondary outcome measures (6)
  • Paris Classification of Crohn's Disease [Time frame: Baseline]
  • Montreal Classification of Crohn's disease [Time frame: Baseline]
  • Paris Classification of Ulcerative Colitis/Indeterminate Colitis [Time frame: Baseline]
  • Montreal Classification of Ulcerative Colitis/Indeterminate Colitis [Time frame: Baseline]
  • Disorder of Gut-Brain Interaction classification [Time frame: Baseline]
  • Physician's Global Assessment (PGA) [Time frame: 3 years]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • Seattle Children's Hospital — Seattle

Identifiers

NCT: NCT06315179 · STUDY00004616

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗