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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06315179
Other study ID # STUDY00004616
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date April 2024
Est. completion date January 2030

Study information

Verified date March 2024
Source Seattle Children's Hospital
Contact Mason E Nuding, BS
Phone 206-987-0055
Email mason.nuding@seattlechildrens.org
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 200
Est. completion date January 2030
Est. primary completion date January 2028
Accepts healthy volunteers No
Gender All
Age group 6 Years to 21 Years
Eligibility 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

Study Design


Intervention

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.
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.

Locations

Country Name City State
United States Seattle Children's Hospital Seattle Washington

Sponsors (2)

Lead Sponsor Collaborator
Seattle Children's Hospital Allen Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. 3 years
Secondary 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
Baseline
Secondary 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
Baseline
Secondary 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
Baseline
Secondary 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
Baseline
Secondary 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
Baseline
Secondary Physician's Global Assessment (PGA) Severity: Quiescent, Mild, Moderate, Severe 3 years
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