Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease

N/AActive Not RecruitingNCT04088773

Children's Hospital Medical Center, Cincinnati232 enrolled

Overview

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).

Study Type

OBSERVATIONAL

Enrollment

232

Conditions

Crohn Disease

Interventions

blood biomarkersDIAGNOSTIC_TEST

biomarkers to distinguish fibrotic vs non-fibrotic CD lesions

stool biomarkersDIAGNOSTIC_TEST

fecal biomarkers of inflammation, mucosal inflammation

MRI imagingDIAGNOSTIC_TEST

MRI imaging to detect bowel wall fibrosis and to detect inflamed, non-fibrotic from inflamed, fibrotic bowel

Eligibility

Sex: ALLMin age: 8 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Aim 1 (CD participants) 1. Aged 8-70 years 2. Undergoing first surgical distal (ileal) small bowel resection for structuring (B2 phenotype) Crohn's disease as determined by CTE or MRE or ileocolonoscopy 3. English speaking * Aim 2 (CD participants) 1. Age 8 to 70 years 2. Uncomplicated inflammatory small bowel CD based on clinical CTE or MRE or ileocolonoscopy performed within 6 months prior to enrollment (CD participants only) 3. English speaking * Aim 2 (Control participants) 1. Age 8 to 70 years 2. English speaking Exclusion Criteria: * Aim1 (CD participants) 1. B1 or B3 (i.e., fistula, abscess, phlegmon/inflammatory mass) CD phenotype 2. Prior small bowel surgery, including but not limited to surgical resection, stricturoplasty, or endoscopic treatment of a small bowel stricture 3. Anything to eat or drink within 4 hours of study visit (participants may take their required medications with a little water) 4. Known pregnancy (Note: Institutional policies/procedures will be followed for pregnancy screening) 5. Contraindication for MRI (e.g., surgical implant, claustrophobia). Note: To be determined based on local procedures. * Aim 2 (CD participants) 1. Stenotic ileocecal valve at colonoscopy 2. Prior small bowel surgery, including but not limited to surgical resection, stricturoplasty, or endoscopic treatment of a small bowel stricture 3. Anything to eat or drink within 4 hours of study visit (participants may take their required medications with a little water) 4. Known pregnancy (Note: Institutional policies/procedures will be followed for pregnancy screening) 5. Contraindication for MRI (e.g., surgical implant, claustrophobia). Note: To be determined based on local procedures. * Aim 2 (Control participants) 1. Any known gastrointestinal tract disease 2. Any known inflammatory/autoimmune disease involving another organ system (e.g., rheumatoid arthritis, scleroderma, multiple sclerosis). 3. Fecal calprotectin level of ˃100 mcg.gm will be excluded from further analysis and replaced.

Locations (4)

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

Outcomes

Primary Outcomes

Magnetization transfer ratio (MTR)

compare MTR values between Aim 1 and Aim 2 cohorts

Time frame: Day 1

Secondary Outcomes

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

Data from ClinicalTrials.gov

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