Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease
NCT ID: NCT04088773
Last Updated: 2025-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
232 participants
OBSERVATIONAL
2019-11-01
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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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
blood biomarkers
biomarkers to distinguish fibrotic vs non-fibrotic CD lesions
stool biomarkers
fecal biomarkers of inflammation, mucosal inflammation
MRI imaging
MRI imaging to detect bowel wall fibrosis and to detect inflamed, non-fibrotic from inflamed, fibrotic bowel
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
blood biomarkers
biomarkers to distinguish fibrotic vs non-fibrotic CD lesions
stool biomarkers
fecal biomarkers of inflammation, mucosal inflammation
MRI imaging
MRI imaging to detect bowel wall fibrosis and to detect inflamed, non-fibrotic from inflamed, fibrotic bowel
Aim 2 Healthy Controls
No intervention; observational only; collection of blood, stool, and completion of Gastrointestinal Symptoms Rating Scale
blood biomarkers
biomarkers to distinguish fibrotic vs non-fibrotic CD lesions
stool biomarkers
fecal biomarkers of inflammation, mucosal inflammation
Interventions
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blood biomarkers
biomarkers to distinguish fibrotic vs non-fibrotic CD lesions
stool biomarkers
fecal biomarkers of inflammation, mucosal inflammation
MRI imaging
MRI imaging to detect bowel wall fibrosis and to detect inflamed, non-fibrotic from inflamed, fibrotic bowel
Eligibility Criteria
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Inclusion Criteria
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
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.
8 Years
70 Years
ALL
Yes
Sponsors
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The Leona M. and Harry B. Helmsley Charitable Trust
OTHER
Children's Hospital Medical Center, Cincinnati
OTHER
Responsible Party
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Principal Investigators
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Jonathan Dillman, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Locations
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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
Countries
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Other Identifiers
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2019-0677
Identifier Type: -
Identifier Source: org_study_id
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