## Protocol Section
### Identification Module
**NCT ID:** NCT06315179

**Acronym:** STRIDE

**Brief Title:** Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation (STRIDE)

**Official Title:** Seattle Spatial Transcriptomic Research in Inflammatory Bowel Disease Evaluation

#### Organization Study ID Info
**ID:** STUDY00004616
#### Organization
**Class:** OTHER
**Full Name:** Seattle Children's Hospital
### Status Module
#### Completion Date
**Date:** 2030-01

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-03-19

**Type:** ACTUAL

**Last Update Submit Date:** 2024-03-15

**Overall Status:** NOT_YET_RECRUITING

#### Primary Completion Date
**Date:** 2028-01

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-04

**Type:** ESTIMATED

**Status Verified Date:** 2024-03

#### Study First Post Date
**Date:** 2024-03-18
**Type:** ACTUAL
**Study First Submit Date:** 2024-03-05
**Study First Submit QC Date:** 2024-03-11
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Allen Institute

#### Lead Sponsor

**Class:** OTHER

**Name:** Seattle Children's Hospital

#### Responsible Party

**Investigator Affiliation:** Seattle Children's Hospital

**Investigator Full Name:** Betty Zheng

**Investigator Title:** Assistant Professor, Director of Advanced IBD Fellowship Program

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

**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 Module

**Conditions:**

- 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

**Keywords:**

- IBD

- DGBI

### Design Module

#### Bio Spec

**Description:** -The blood and tissue bio-specimens obtained for this research will undergo genetic testing including but not limited to single-cell analysis, exome sequencing, and whole genome sequencing, gene editing, and organoid generation (results will not be provided to participants and/or their care providers). Cells are not 'immortalized' and will eventually expire.

**Retention:** SAMPLES_WITH_DNA

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 200

**Type:** ESTIMATED

**Patient Registry:** True

**Study Type:** OBSERVATIONAL

**Target Duration:** 3 Years

### Arms Interventions Module

#### Arm Group 1

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: Esophagogastroduodenoscopy (EGD) with biopsy

- Diagnostic Test: Colonoscopy w/ biopsy

**Label:** Inflammatory Bowel Disease

#### Arm Group 2

**Description:** 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.

**Intervention Names:**

- Diagnostic Test: Esophagogastroduodenoscopy (EGD) with biopsy

- Diagnostic Test: Colonoscopy w/ biopsy

**Label:** Disorders of the Brain-Gut Interactions

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Disorders of the Brain-Gut Interactions

- Inflammatory Bowel Disease

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

**Name:** Esophagogastroduodenoscopy (EGD) with biopsy

**Type:** DIAGNOSTIC_TEST

#### Intervention 2

**Arm Group Labels:**

- Disorders of the Brain-Gut Interactions

- Inflammatory Bowel Disease

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

**Name:** Colonoscopy w/ biopsy

**Type:** DIAGNOSTIC_TEST

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** Bio-repository sample collection for spatial transcriptomics

**Time Frame:** 3 years

#### Secondary Outcomes

**Description:** * 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

**Measure:** Paris Classification of Crohn's Disease

**Time Frame:** Baseline

**Description:** * 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

**Measure:** Montreal Classification of Crohn's disease

**Time Frame:** Baseline

**Description:** * 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

**Measure:** Paris Classification of Ulcerative Colitis/Indeterminate Colitis

**Time Frame:** Baseline

**Description:** * 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

**Measure:** Montreal Classification of Ulcerative Colitis/Indeterminate Colitis

**Time Frame:** Baseline

**Description:** 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

**Measure:** Disorder of Gut-Brain Interaction classification

**Time Frame:** Baseline

**Description:** Severity: Quiescent, Mild, Moderate, Severe

**Measure:** Physician's Global Assessment (PGA)

**Time Frame:** 3 years

### Eligibility Module

**Eligibility Criteria:** 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

**Maximum Age:** 21 Years

**Minimum Age:** 6 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

**Study Population:** All individuals who meet inclusion criteria will be approached.

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** mason.nuding@seattlechildrens.org

**Name:** Mason E Nuding, BS

**Phone:** 206-987-0055

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Seattle

**Contacts:**

***Contact 1:***

- **Email:** mason.nuding@seattlechildrens.org

- **Name:** Mason E Nuding

- **Phone:** 206-987-0055

- **Role:** CONTACT

***Contact 2:***

- **Email:** giresearch@seattlechidlrens.org

- **Name:** Clinical Research Coordinator

- **Phone:** 206-987-2521

- **Role:** CONTACT

***Contact 3:***

- **Name:** Hengqi Zheng, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** United States

**Facility:** Seattle Children's Hospital

**State:** Washington

**Zip:** 98105

#### Overall Officials

**Official 1:**

**Affiliation:** Seattle Children's Hospital, University of Washington

**Name:** Betty (Hengqi) Zheng, MD

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000005759

- Term: Gastroenteritis

- ID: D000005767

- Term: Gastrointestinal Diseases

- ID: D000004066

- Term: Digestive System Diseases

- ID: D000003108

- Term: Colonic Diseases

- ID: D000010146

- Term: Pain

- ID: D000009461

- Term: Neurologic Manifestations

- ID: D000012817

- Term: Signs and Symptoms, Digestive

- ID: D000001660

- Term: Biliary Tract Diseases

- ID: D000001657

- Term: Biliary Dyskinesia

- ID: D000003137

- Term: Common Bile Duct Diseases

- ID: D000001649

- Term: Bile Duct Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC06

- Name: Digestive System Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M6638

- Name: Crohn Disease

- Relevance: HIGH

- As Found: Crohn's Disease

- ID: M16355

- Name: Syndrome

- Relevance: LOW

- As Found: Unknown

- ID: M10444

- Name: Intestinal Diseases

- Relevance: HIGH

- As Found: Bowel Disease

- ID: M17917

- Name: Inflammatory Bowel Diseases

- Relevance: HIGH

- As Found: Inflammatory Bowel Disease

- ID: M6320

- Name: Colitis

- Relevance: HIGH

- As Found: Colitis

- ID: M18311

- Name: Abdominal Pain

- Relevance: HIGH

- As Found: Abdominal Pain

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M6321

- Name: Colitis, Ulcerative

- Relevance: LOW

- As Found: Unknown

- ID: M17206

- Name: Ulcer

- Relevance: LOW

- As Found: Unknown

- ID: M8085

- Name: Esophageal Diseases

- Relevance: HIGH

- As Found: Esophageal Diseases

- ID: M8823

- Name: Gallbladder Diseases

- Relevance: HIGH

- As Found: Gallbladder Diseases

- ID: M25690

- Name: Sphincter of Oddi Dysfunction

- Relevance: HIGH

- As Found: Sphincter of Oddi Dysfunction

- ID: M14844

- Name: Rectal Diseases

- Relevance: HIGH

- As Found: Anorectal Disorder

- ID: M8875

- Name: Gastroenteritis

- Relevance: LOW

- As Found: Unknown

- ID: M7255

- Name: Digestive System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8883

- Name: Gastrointestinal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6336

- Name: Colonic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12404

- Name: Neurologic Manifestations

- Relevance: LOW

- As Found: Unknown

- ID: M15622

- Name: Signs and Symptoms, Digestive

- Relevance: LOW

- As Found: Unknown

- ID: M4946

- Name: Biliary Tract Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M22574

- Name: Dyskinesias

- Relevance: LOW

- As Found: Unknown

- ID: M4943

- Name: Biliary Dyskinesia

- Relevance: LOW

- As Found: Unknown

- ID: M4935

- Name: Bile Duct Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M6364

- Name: Common Bile Duct Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003424

- Term: Crohn Disease

- ID: D000003092

- Term: Colitis

- ID: D000007410

- Term: Intestinal Diseases

- ID: D000015212

- Term: Inflammatory Bowel Diseases

- ID: D000004935

- Term: Esophageal Diseases

- ID: D000005705

- Term: Gallbladder Diseases

- ID: D000012002

- Term: Rectal Diseases

- ID: D000046628

- Term: Sphincter of Oddi Dysfunction

- ID: D000015746

- Term: Abdominal Pain

### Intervention Browse Module - Browse Branches

- Abbrev: HB

- Name: Herbal and Botanical

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: T120

- Name: Cola

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
