Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease
1 other identifier
observational
232
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2019
Longer than P75 for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 12, 2019
CompletedFirst Posted
Study publicly available on registry
September 13, 2019
CompletedStudy Start
First participant enrolled
November 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
ExpectedJune 13, 2025
June 1, 2025
3.8 years
September 12, 2019
June 11, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Magnetization transfer ratio (MTR)
compare MTR values between Aim 1 and Aim 2 cohorts
Day 1
Secondary Outcomes (1)
Correlation between MTR values and bowel wall collagen measurements
Day 1
Study Arms (3)
Aim 1 Crohn Disease participants (B2 phenotype)
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)
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
No intervention; observational only; collection of blood, stool, and completion of Gastrointestinal Symptoms Rating Scale
Interventions
biomarkers to distinguish fibrotic vs non-fibrotic CD lesions
fecal biomarkers of inflammation, mucosal inflammation
MRI imaging to detect bowel wall fibrosis and to detect inflamed, non-fibrotic from inflamed, fibrotic bowel
Eligibility Criteria
Aim 1 - Children and adults undergoing surgical small bowel resection for structuring CD; Aim 2 - children and adults that have known uncomplicated inflammatory small bowel CD (B1phenotype) AND healthy non-IBD participants
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).
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Emory/Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Michigan Medicine
Ann Arbor, Michigan, 48109, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Dillman, MD, MSc
Children's Hospital Medical Center, Cincinnati
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 12, 2019
First Posted
September 13, 2019
Study Start
November 1, 2019
Primary Completion
September 1, 2023
Study Completion (Estimated)
June 1, 2026
Last Updated
June 13, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share