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

NCT ID: NCT06315179

Last Updated: 2025-05-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-05-10

Study Completion Date

2030-01-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Inflammatory Bowel Disease

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.

Esophagogastroduodenoscopy (EGD) with biopsy

Intervention Type DIAGNOSTIC_TEST

Esophagogastroduodenoscopy (EGD) is a test procedure to examine the lining of the esophagus, stomach, and first part of the small intestine.

Colonoscopy w/ biopsy

Intervention Type DIAGNOSTIC_TEST

Colonoscopy is a test procedure to examine the lining of the different portions of the large intestine: cecum, colon, rectum, and anal canal.

Disorders of the Brain-Gut Interactions

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.

Esophagogastroduodenoscopy (EGD) with biopsy

Intervention Type DIAGNOSTIC_TEST

Esophagogastroduodenoscopy (EGD) is a test procedure to examine the lining of the esophagus, stomach, and first part of the small intestine.

Colonoscopy w/ biopsy

Intervention Type DIAGNOSTIC_TEST

Colonoscopy is a test procedure to examine the lining of the different portions of the large intestine: cecum, colon, rectum, and anal canal.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Allen Institute

UNKNOWN

Sponsor Role collaborator

Seattle Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Betty Zheng

Assistant Professor, Director of Advanced IBD Fellowship Program

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Betty (Hengqi) Zheng, MD

Role: PRINCIPAL_INVESTIGATOR

Seattle Children's Hospital, University of Washington

Locations

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Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mason E Nuding, BS

Role: CONTACT

206-987-0055

Facility Contacts

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Mason E Nuding

Role: primary

206-987-0055

Clinical Research Coordinator

Role: backup

206-987-2521

Other Identifiers

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STUDY00004616

Identifier Type: -

Identifier Source: org_study_id

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