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| Name | Class |
|---|---|
| Allen Institute | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Esophagogastroduodenoscopy (EGD) with biopsy | Diagnostic Test | Esophagogastroduodenoscopy (EGD) is a test procedure to examine the lining of the esophagus, stomach, and first part of the small intestine. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Paris Classification of Crohn's Disease |
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Inclusion Criteria:
Exclusion Criteria:
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All individuals who meet inclusion criteria will be approached.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mason E Nuding, BS | Contact | 206-987-0055 | mason.nuding@seattlechildrens.org |
| Name | Affiliation | Role |
|---|---|---|
| Betty (Hengqi) Zheng, MD | Seattle Children's Hospital, University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98105 | United States |
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-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.
| Colonoscopy w/ biopsy | 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. |
|
| Baseline |
| Montreal Classification of Crohn's disease |
| Baseline |
| Paris Classification of Ulcerative Colitis/Indeterminate Colitis |
| Baseline |
| Montreal Classification of Ulcerative Colitis/Indeterminate Colitis |
| Baseline |
| Disorder of Gut-Brain Interaction classification | Diagnoses super-type and applicable sub type:
| Baseline |
| Physician's Global Assessment (PGA) | Severity: Quiescent, Mild, Moderate, Severe | 3 years |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D003424 | Crohn Disease |
| D003093 | Colitis, Ulcerative |
| D004935 | Esophageal Diseases |
| D007410 | Intestinal Diseases |
| D005705 | Gallbladder Diseases |
| D046628 | Sphincter of Oddi Dysfunction |
| D012002 | Rectal Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D003092 | Colitis |
| D003108 | Colonic Diseases |
| D001660 | Biliary Tract Diseases |
| D001657 | Biliary Dyskinesia |
| D003137 | Common Bile Duct Diseases |
| D001649 | Bile Duct Diseases |
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| ID | Term |
|---|---|
| D016145 | Endoscopy, Digestive System |
| D001706 | Biopsy |
| ID | Term |
|---|---|
| D003938 | Diagnostic Techniques, Digestive System |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| D003581 | Cytodiagnosis |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D013048 | Specimen Handling |
| D008919 | Investigative Techniques |
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