An observational study in Inflammatory Bowel Diseases, Crohn Disease and Ulcerative Colitis, sponsored by Seattle Children's Hospital. Recruiting at 1 site in United States. Open to participants aged 6 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-04-24.
Sponsored by Seattle Children's Hospital · Observational
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.
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.
1,550 studies on the registry are indexed under Inflammatory Bowel Diseases; 426 are open to participants now.
This study's planned enrollment of 200 is above the median of 140 across 626 observational studies indexed under Inflammatory Bowel Diseases.
Browse Inflammatory Bowel Diseases studies →Seattle Children's Hospital is the lead sponsor of 215 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All individuals who meet inclusion criteria will be approached.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
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
Esophagogastroduodenoscopy (EGD) is a test procedure to examine the lining of the esophagus, stomach, and first part of the small intestine.
Colonoscopy is a test procedure to examine the lining of the different portions of the large intestine: cecum, colon, rectum, and anal canal.
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
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
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
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
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
Disorder of Gut-Brain Interaction classification
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
Time frame: Baseline
Physician's Global Assessment (PGA)
Severity: Quiescent, Mild, Moderate, Severe
Time frame: 3 years
Plan to share: No
No publications or documents are linked to this record.
Started May 2024 (actual). Primary completion is estimated for Jan 2028, 44 months after the start.
Of 243 non-industry observational studies under Inflammatory Bowel Diseases, half reached primary completion within 38 months of starting (the median), counting those still running; a quarter within 20 and three quarters within 132. This study's planned 44 months is above that.
Counting every sponsor, half of 280 studies reached it within 36 months; a quarter within 20 and three quarters within 122.
How these figures are worked out, and which studies are left out of them.
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