Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease
Running, not enrolling
Conditions studied: Crohn Disease
In brief
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.
Key facts
- Study ID
- NCT04088773
- Run by
- Children's Hospital Medical Center, Cincinnati
- People needed
- 232
- Starts
- 2019-11-01
- Expected to finish
- 2026-06-01
- Last updated by the study team
- 2025-06-13
Who can join
Age: 8 and older, up to 70. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Emory/Children's Healthcare of Atlanta — Atlanta, Georgia, United States
- Michigan Medicine — Ann Arbor, Michigan, United States
- Mayo Clinic — Rochester, Minnesota, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
Full record on ClinicalTrials.gov
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