Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| The Leona M. and Harry B. Helmsley Charitable Trust | OTHER |
Not provided
Not provided
Not provided
This research study will evaluate if specific blood, stool and MRI tests can tell the difference between bowel wall inflammation without scarring and bowel wall inflammation with scarring that can cause bowel blockages requiring surgery.
This multi-center study will test the accuracy of individual and combined MRI and blood-based diagnostic tools in both children and adults with small bowel CD. We will determine the accuracy of a composite tool (including its multiple individual biomarkers) for defining the relative amounts of intestinal inflammation versus scarring in patients at the time of surgery (B2 disease) and in patients at an early stage of disease prior to complications (B1 disease).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Aim 1 Crohn Disease participants (B2 phenotype) | Crohn's Disease participants scheduled for ileal small bowel resection; No intervention; observational only; collection of blood, stool, and perform MRI; completion of Crohn's Activity Questionnaire |
| |
| Aim 2 Crohn Disease participants (B1 phenotype) | Crohn's Disease participants with uncomplicated small bowel disease; No intervention; observational only; collection of blood, stool, and perform MRI; completion of Crohn's Activity Questionnaire |
| |
| Aim 2 Healthy Controls | No intervention; observational only; collection of blood, stool, and completion of Gastrointestinal Symptoms Rating Scale |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| blood biomarkers | Diagnostic Test | biomarkers to distinguish fibrotic vs non-fibrotic CD lesions |
|
| Measure | Description | Time Frame |
|---|---|---|
| Magnetization transfer ratio (MTR) | compare MTR values between Aim 1 and Aim 2 cohorts | Day 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation between MTR values and bowel wall collagen measurements | combine all subjects from Aim 1 and Aim 2 that undergo MRI | Day 1 |
Not provided
Inclusion Criteria:
Aim 1 (CD participants)
Aim 2 (CD participants)
Aim 2 (Control participants)
Exclusion Criteria:
Aim1 (CD participants)
Aim 2 (CD participants)
Aim 2 (Control participants)
Not provided
Not provided
Aim 1 - Children and adults undergoing surgical small bowel resection for structuring CD; Aim 2 - children and adults that have known uncomplicated inflammatory small bowel CD (B1phenotype) AND healthy non-IBD participants
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Dillman, MD, MSc | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory/Children's Healthcare of Atlanta | Atlanta | Georgia | 30322 | United States | ||
| Michigan Medicine |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
| stool biomarkers | Diagnostic Test | fecal biomarkers of inflammation, mucosal inflammation |
|
| MRI imaging | Diagnostic Test | MRI imaging to detect bowel wall fibrosis and to detect inflamed, non-fibrotic from inflamed, fibrotic bowel |
|
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Cincinnati Children's Hospital Medical Center | Cincinnati | Ohio | 45229 | United States |
| D007410 | Intestinal Diseases |