Status:
ACTIVE_NOT_RECRUITING
Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease
Lead Sponsor:
Children's Hospital Medical Center, Cincinnati
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
Conditions:
Crohn Disease
Eligibility:
All Genders
8-70 years
Brief Summary
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 cau...
Detailed Description
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 comp...
Eligibility Criteria
Inclusion
- Aim 1 (CD participants)
- Aged 8-70 years
- Undergoing first surgical distal (ileal) small bowel resection for structuring (B2 phenotype) Crohn's disease as determined by CTE or MRE or ileocolonoscopy
- English speaking
- Aim 2 (CD participants)
- Age 8 to 70 years
- Uncomplicated inflammatory small bowel CD based on clinical CTE or MRE or ileocolonoscopy performed within 6 months prior to enrollment (CD participants only)
- English speaking
- Aim 2 (Control participants)
- Age 8 to 70 years
- English speaking
Exclusion
- Aim1 (CD participants)
- B1 or B3 (i.e., fistula, abscess, phlegmon/inflammatory mass) CD phenotype
- Prior small bowel surgery, including but not limited to surgical resection, stricturoplasty, or endoscopic treatment of a small bowel stricture
- Anything to eat or drink within 4 hours of study visit (participants may take their required medications with a little water)
- Known pregnancy (Note: Institutional policies/procedures will be followed for pregnancy screening)
- Contraindication for MRI (e.g., surgical implant, claustrophobia). Note: To be determined based on local procedures.
- Aim 2 (CD participants)
- Stenotic ileocecal valve at colonoscopy
- Prior small bowel surgery, including but not limited to surgical resection, stricturoplasty, or endoscopic treatment of a small bowel stricture
- Anything to eat or drink within 4 hours of study visit (participants may take their required medications with a little water)
- Known pregnancy (Note: Institutional policies/procedures will be followed for pregnancy screening)
- Contraindication for MRI (e.g., surgical implant, claustrophobia). Note: To be determined based on local procedures.
- Aim 2 (Control participants)
- Any known gastrointestinal tract disease
- Any known inflammatory/autoimmune disease involving another organ system (e.g., rheumatoid arthritis, scleroderma, multiple sclerosis).
- Fecal calprotectin level of ˃100 mcg.gm will be excluded from further analysis and replaced.
Key Trial Info
Start Date :
November 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2026
Estimated Enrollment :
232 Patients enrolled
Trial Details
Trial ID
NCT04088773
Start Date
November 1 2019
End Date
June 1 2026
Last Update
June 13 2025
Active Locations (4)
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1
Emory/Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
2
Michigan Medicine
Ann Arbor, Michigan, United States, 48109
3
Mayo Clinic
Rochester, Minnesota, United States, 55905
4
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229