Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease (NCT04088773) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease
United States232 participantsStarted 2019-11-01
Plain-language 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 cause bowel blockages requiring surgery.
Who can participate
Age range8 Years – 70 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. 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
✓. Age 8 to 70 years
✓. English speaking
Exclusion criteria
✕. 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.
What they're measuring
1
Magnetization transfer ratio (MTR)
Timeframe: Day 1
Trial details
NCT IDNCT04088773
SponsorChildren's Hospital Medical Center, Cincinnati