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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age6-21
SponsorSeattle Children's Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Other serious medical conditions, such as neurological, liver, kidney, or systemic disease

Pregnancy

Tobacco, alcohol, or illicit drug abuse

Trial population

All individuals who meet inclusion criteria will be approached.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • 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.

Treatment groups

200 Participants
are divided into 2 treatment groups
Group A: Inflammatory Bowel Disease2 interventions
Group B: Disorders of the Brain-Gut Interactions2 interventions

Trial outcomes

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.

Time frame
3 years

Secondary outcomes

1

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

Time frame
Baseline
2

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

Time frame
Baseline
3

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

Time frame
Baseline
4

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

Time frame
Baseline

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Seattle Children's Hospital

Lead sponsor

Allen Institute

Collaborator