An observational study in Crohn Disease, sponsored by Children's Hospital Medical Center, Cincinnati. Active, not recruiting at 4 sites in United States. Open to participants aged 8 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-06-13.
Sponsored by Children's Hospital Medical Center, Cincinnati · Observational
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).
1,880 studies on the registry are indexed under Crohn Disease; 462 are open to participants now.
This study's planned enrollment of 232 is above the median of 162 across 608 observational studies indexed under Crohn Disease.
Browse Crohn Disease studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
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
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)
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
Diagnostic Test: blood biomarkers · Diagnostic Test: stool biomarkers · Diagnostic Test: MRI imaging
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
Diagnostic Test: blood biomarkers · Diagnostic Test: stool biomarkers · Diagnostic Test: MRI imaging
No intervention; observational only; collection of blood, stool, and completion of Gastrointestinal Symptoms Rating Scale
Diagnostic Test: blood biomarkers · Diagnostic Test: stool biomarkers
biomarkers to distinguish fibrotic vs non-fibrotic CD lesions
fecal biomarkers of inflammation, mucosal inflammation
MRI imaging to detect bowel wall fibrosis and to detect inflamed, non-fibrotic from inflamed, fibrotic bowel
Magnetization transfer ratio (MTR)
compare MTR values between Aim 1 and Aim 2 cohorts
Time frame: Day 1
Correlation between MTR values and bowel wall collagen measurements
combine all subjects from Aim 1 and Aim 2 that undergo MRI
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jun 2025. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati