NCT04088773Active, not recruiting
Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease
Source: ClinicalTrials.gov · Last updated 13 Jun 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Observational
- Enrollment
- 232 (estimated)
- First submitted
- 12 Sept 2019
- Start date
- 1 Nov 2019
- Primary completion date
- 1 Sept 2023
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Diseases
- Crohn's disease
- NCT number
- NCT04088773
What you commit to
- Study type: Observational
- Planned participants: 232
- From 1 Nov 2019 to the primary completion date, 1 Sept 2023
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- 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.
Who the study is looking for
- 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
Age in the registry: 8 years to 70 years · Sex: All · Accepts healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Michigan Medicine Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Emory/Children's Healthcare of Atlanta Coordinator of this site? Confirm its status | Atlanta | United States | Unknown status |
| Cincinnati Children's Hospital Medical Center Coordinator of this site? Confirm its status | Cincinnati | United States | Unknown status |
| Mayo Clinic Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.