Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease

Active, not recruiting

• Conditions: Crohn Disease
• Interventions: Diagnostic Test: blood biomarkers; Diagnostic Test: stool biomarkers; Diagnostic Test: MRI imaging

• Registration Number: NCT04088773
• Lead Sponsor: Children's Hospital Medical Center, Cincinnati

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2019-09-12
• Study First Submitted QC: 2019-09-12
• Study First Posted: 2019-09-13
• Study Start: 2019-11-01
• Status Verified: 2023-09
• Primary Completion: 2023-09-01
• Last Update Submitted: 2023-09-26
• Last Update Posted: 2023-09-28
• Study Completion: 2024-09

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 232

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Aim 2 Healthy Controls	blood biomarkers	No intervention; observational only; collection of blood, stool, and completion of Gastrointestinal Symptoms Rating Scale
Aim 1 Crohn Disease participants (B2 phenotype)	blood biomarkers	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
Aim 1 Crohn Disease participants (B2 phenotype)	MRI imaging	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
Aim 2 Crohn Disease participants (B1 phenotype)	blood biomarkers	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
Aim 2 Crohn Disease participants (B1 phenotype)	stool biomarkers	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
Aim 2 Healthy Controls	stool biomarkers	No intervention; observational only; collection of blood, stool, and completion of Gastrointestinal Symptoms Rating Scale
Aim 2 Crohn Disease participants (B1 phenotype)	MRI imaging	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
Aim 1 Crohn Disease participants (B2 phenotype)	stool biomarkers	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

Primary Outcome Measures

Name	Time	Method
Magnetization transfer ratio (MTR)	Day 1	compare MTR values between Aim 1 and Aim 2 cohorts

Secondary Outcome Measures

Name	Time	Method
Correlation between MTR values and bowel wall collagen measurements	Day 1	combine all subjects from Aim 1 and Aim 2 that undergo MRI

Trial Locations

Locations (4)

Emory/Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Michigan Medicine; 🇺🇸 Ann Arbor, Michigan, United States