Recruiting

Observational Study

Sponsor:

Seattle Children's Hospital

Code:

NCT06315179

Conditions

Inflammatory Bowel Diseases

Crohn Disease

Ulcerative Colitis

Indeterminate Colitis

Functional Abdominal Pain Syndrome

Eligibility Criteria

Sex: All

Age: 6 - 21

Healthy Volunteers: Not accepted

Interventions

Esophagogastroduodenoscopy (EGD) with biopsy

Colonoscopy w/ biopsy

Study Details

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.

Conditions

Inflammatory Bowel Diseases

Crohn Disease

Ulcerative Colitis

Indeterminate Colitis

Functional Abdominal Pain Syndrome

Study ID

NCT06315179

Start date

May 10, 2024

Status verified date

Apr, 2026

Completion date

Jan, 2030

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6 - 21

Healthy Volunteers: Not accepted

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

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Primary outcome measure

  • Bio-repository sample collection for spatial transcriptomics [ Time Frame: 3 years ]

Central Contacts and Locations

Central contacts

Mason E Nuding, BS

206-987-0055mason.nuding@seattlechildrens.org

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Mason E Nuding

206-987-0055mason.nuding@seattlechildrens.org

Clinical Research Coordinator

206-987-2521giresearch@seattlechidlrens.org

Principal Investigator:

Hengqi Zheng, MD

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Keywords

  • IBD
  • DGBI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2026-04-24.