Inflammatory Bowel DiseasesSTRIDENCT06315179
Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Seattle Children's Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 6 to 21 years
- Conditions the study is for
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis
- What is being tested?
- Esophagogastroduodenoscopy (EGD) with biopsy and Colonoscopy w/ biopsy
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2024to Jan 2030
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All individuals who meet inclusion criteria will be approached.
Who may be able to join
- Suspected diagnosis of CD (Crohn's Disease), UC (Ulcerative Colitis) or Indeterminate colitis (IC)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
Mason E Nuding, 206-987-0055, mason.nuding@seattlechildrens.org
Clinical Research Coordinator, 206-987-2521, giresearch@seattlechidlrens.org
About this study
Official title: Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation
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.
Read the 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.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Indeterminate Colitis, Functional Abdominal Pain Syndrome, Functional Bowel Disorder
- Being tested
- Esophagogastroduodenoscopy (EGD) with biopsy, Colonoscopy w/ biopsy
- Keywords
- IBD, DGBI
- Medical subject headings
- Inflammatory Bowel Diseases, Crohn Disease, Colitis, Ulcerative, Esophageal Diseases, Intestinal Diseases, Gallbladder Diseases, Sphincter of Oddi Dysfunction, Rectal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Esophagogastroduodenoscopy (EGD) with biopsyDiagnostic test
Esophagogastroduodenoscopy (EGD) is a test procedure to examine the lining of the esophagus, stomach, and first part of the small intestine.
Colonoscopy w/ biopsyDiagnostic test
Colonoscopy is a test procedure to examine the lining of the different portions of the large intestine: cecum, colon, rectum, and anal canal.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Esophagogastroduodenoscopy (EGD) with biopsy; Diagnostic Test: Colonoscopy w/ biopsy | |
| 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. Receives: Diagnostic Test: Esophagogastroduodenoscopy (EGD) with biopsy; Diagnostic Test: Colonoscopy w/ biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 years
Secondary outcomes (6)
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
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
Measured: Baseline
Physician's Global Assessment (PGA)
Severity: Quiescent, Mild, Moderate, Severe
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start10 May 2024
- Primary completionJan 2028 (estimated)
- Study completionJan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflammatory Bowel DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Seattle Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Allen Institute
- Responsible party
- Principal investigator, Betty Zheng, Seattle Children's Hospital
- Investigators
- Betty (Hengqi) Zheng, MD, Principal investigator, Seattle Children's Hospital, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315179
- Sponsor's protocol ID
- STUDY00004616
- Acronym
- STRIDE
- Status last verified
- Apr 2026
- First submitted
- 5 Mar 2024
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation
- ClinicalTrials.gov ID
- NCT06315179
- Acronym / sponsor ID
- STRIDE / STUDY00004616
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, Indeterminate Colitis, Functional Abdominal Pain Syndrome, Functional Bowel Disorder
- Keywords
- IBD, DGBI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Seattle Children's HospitalUniversity, hospital or other
- Collaborators
- Allen Institute
- Study start
- 10 May 2024 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2030 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Inflammatory Bowel Disease | – | Diagnostic Test: Esophagogastroduodenoscopy (EGD) with biopsy, Diagnostic Test: Colonoscopy w/ biopsyParticipants 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 | – | Diagnostic Test: Esophagogastroduodenoscopy (EGD) with biopsy, Diagnostic Test: Colonoscopy w/ biopsyParticipants 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. |
Who may qualify
- Ages
- 6 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All individuals who meet inclusion criteria will be approached.
Key inclusion criteria (1 listed)
- Suspected diagnosis of CD (Crohn's Disease), UC (Ulcerative Colitis) or Indeterminate colitis (IC)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Esophagogastroduodenoscopy (EGD) with biopsyEsophagogastroduodenoscopy (EGD) is a test procedure to examine the lining of the esophagus, stomach, and first part of the small intestine. | Diagnostic test | Disorders of the Brain-Gut Interactions, Inflammatory Bowel Disease |
| Colonoscopy w/ biopsyColonoscopy is a test procedure to examine the lining of the different portions of the large intestine: cecum, colon, rectum, and anal canal. | Diagnostic test | Disorders of the Brain-Gut Interactions, Inflammatory Bowel Disease |
Primary outcome
Bio-repository sample collection for spatial transcriptomics
Time frame: 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.
6 secondary outcomes
Paris Classification of Crohn's Disease
Time frame: Baseline
Montreal Classification of Crohn's disease
Time frame: Baseline
Paris Classification of Ulcerative Colitis/Indeterminate Colitis
Time frame: Baseline
Montreal Classification of Ulcerative Colitis/Indeterminate Colitis
Time frame: Baseline
Disorder of Gut-Brain Interaction classification
Time frame: Baseline
Physician's Global Assessment (PGA)
Time frame: 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Betty (Hengqi) Zheng, MD principal investigator
Seattle Children's Hospital, University of Washington
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflammatory Bowel Diseases and Crohn Disease, run by Seattle Children's Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mason E Nuding, BS (206-987-0055, mason.nuding@seattlechildrens.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bio-repository sample collection for spatial transcriptomics (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.