Anorectal Disorder, Bowel Dysfunction, Crohn Disease, Esophageal Diseases, Functional Abdominal Pain Syndrome, Functional Bowel Disorder, Gallbladder Diseases, Gastroduodenal Disorder, Indeterminate Colitis, Inflammatory Bowel Diseases, Sphincter of Oddi Dysfunction, Ulcerative Colitis
Conditions
Keywords
IBD, DGBI
Brief summary
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_TESTEsophagogastroduodenoscopy (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_TESTColonoscopy 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.
Sponsors
Seattle Children's Hospital
Allen Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bio-repository sample collection for spatial transcriptomics | 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
| Measure | Time frame | Description |
|---|---|---|
| Paris Classification of Crohn's Disease | 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 |
| Montreal Classification of Crohn's disease | 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 |
| Paris Classification of Ulcerative Colitis/Indeterminate Colitis | 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 |
| Montreal Classification of Ulcerative Colitis/Indeterminate Colitis | 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 |
| Disorder of Gut-Brain Interaction classification | 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 |
| Physician's Global Assessment (PGA) | 3 years | Severity: Quiescent, Mild, Moderate, Severe |
Countries
United States
Contacts
CONTACTMason E Nuding, BS
PRINCIPAL_INVESTIGATORBetty (Hengqi) Zheng, MD
Seattle Children's Hospital, University of Washington
Outcome results
None listed