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

Ulcerative Colitis Clinical Trial

— STRIDE  

Official title:

Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06315179
• Other study ID #: STUDY00004616
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Abdominal Pain
• Anorectal Disorder
• Bowel Dysfunction
• Colitis
• Crohn Disease
• Esophageal Diseases
• Functional Abdominal Pain Syndrome
• Functional Bowel Disorder
• Gallbladder Diseases
• Indeterminate Colitis
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Rectal Diseases
• Sphincter of Oddi Dysfunction
• Ulcerative Colitis

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