Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease

Cincinnati Children's Hospital Medical Center

Status: Active, not recruiting

Conditions: Crohn Disease

Treatments: Diagnostic Test: MRI imaging; Diagnostic Test: stool biomarkers; Diagnostic Test: blood biomarkers

Study type: Observational

Funder types: Other

Identifiers

NCT04088773

2019-0677

Details and patient eligibility

About

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.

Full 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 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).

Enrollment: 232 estimated patients

Sex: All

Ages: 8 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

232 participants in 3 patient groups

Aim 1 Crohn Disease participants (B2 phenotype)

Description:

Crohn's Disease participants scheduled for ileal small bowel resection; No intervention; observational only; collection of blood, stool, and perform MRI; completion of Crohn's Activity Questionnaire

Treatment:

Diagnostic Test: blood biomarkers

Diagnostic Test: stool biomarkers

Diagnostic Test: MRI imaging

Aim 2 Crohn Disease participants (B1 phenotype)

Description:

Crohn's Disease participants with uncomplicated small bowel disease; No intervention; observational only; collection of blood, stool, and perform MRI; completion of Crohn's Activity Questionnaire

Treatment:

Diagnostic Test: blood biomarkers

Diagnostic Test: stool biomarkers

Diagnostic Test: MRI imaging

Aim 2 Healthy Controls

Description:

No intervention; observational only; collection of blood, stool, and completion of Gastrointestinal Symptoms Rating Scale

Treatment:

Diagnostic Test: blood biomarkers

Diagnostic Test: stool biomarkers