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 volunteersQualifiers
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
Cohort
Prospective
Treatments tested in this trial
Esophagogastroduodenoscopy (EGD) with biopsy
Diagnostic testEsophagogastroduodenoscopy (EGD) is a test procedure to examine the lining of the esophagus, stomach, and first part of the small intestine.
Colonoscopy w/ biopsy
Diagnostic testColonoscopy is a test procedure to examine the lining of the different portions of the large intestine: cecum, colon, rectum, and anal canal.
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
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
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
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
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
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Seattle Children's Hospital
Lead sponsor
Allen Institute
Collaborator