Crohn DiseaseNCT04088773
Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease
An observational study of Crohn Disease, run by Children's Hospital Medical Center, Cincinnati at 4 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Crohn Disease
- What is being tested?
- blood biomarkers, stool biomarkers and MRI imaging
- How many people
- 232 participants
- Where
- 4 sitesUnited States
- Study dates
- 1 Nov 2019to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 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
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.
Show all 16Show fewer
- 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).
- Fecal calprotectin level of ˃100 mcg.gm will be excluded from further analysis and replaced.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Michigan Medicine
Ann Arbor, Michigan, 48109
Emory/Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Mayo Clinic
Rochester, Minnesota, 55905
About this study
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.
Read the 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).
- Conditions
- Crohn Disease
- Being tested
- blood biomarkers, stool biomarkers, MRI imaging
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: blood biomarkers; Diagnostic Test: stool biomarkers; Diagnostic Test: MRI imaging | |
| 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 Receives: Diagnostic Test: blood biomarkers; Diagnostic Test: stool biomarkers; Diagnostic Test: MRI imaging | |
| Aim 2 Healthy Controls | No intervention; observational only; collection of blood, stool, and completion of Gastrointestinal Symptoms Rating Scale Receives: Diagnostic Test: blood biomarkers; Diagnostic Test: stool biomarkers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetization transfer ratio (MTR)
compare MTR values between Aim 1 and Aim 2 cohorts
Measured: Day 1
Secondary outcomes (1)
Correlation between MTR values and bowel wall collagen measurements
combine all subjects from Aim 1 and Aim 2 that undergo MRI
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2019
- Study start1 Nov 2019
- Primary completion1 Sep 2023
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Children's Hospital Medical Center, CincinnatiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 232 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Children's Hospital Medical Center, Cincinnati
- Sponsor type
- University, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Responsible party
- Sponsor
- Investigators
- Jonathan Dillman, MD, MSc, Principal investigator, Children's Hospital Medical Center, Cincinnati
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04088773
- Sponsor's protocol ID
- 2019-0677
- Status last verified
- Jun 2025
- First submitted
- 12 Sep 2019
- Last updated
- 13 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease
- ClinicalTrials.gov ID
- NCT04088773
- Acronym / sponsor ID
- 2019-0677
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 232 participants (estimated)
- Lead sponsor
- Children's Hospital Medical Center, CincinnatiUniversity, hospital or other
- Collaborators
- The Leona M. and Harry B. Helmsley Charitable Trust
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- Jun 2026 (estimated)
- First posted
- 13 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Aim 1 Crohn Disease participants (B2 phenotype) | – | Diagnostic Test: blood biomarkers, Diagnostic Test: stool biomarkers, Diagnostic Test: MRI imagingCrohn'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) | – | Diagnostic Test: blood biomarkers, Diagnostic Test: stool biomarkers, Diagnostic Test: MRI imagingCrohn'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 | – | Diagnostic Test: blood biomarkers, Diagnostic Test: stool biomarkersNo intervention; observational only; collection of blood, stool, and completion of Gastrointestinal Symptoms Rating Scale |
Who may qualify
- Ages
- 8 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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
Key inclusion criteria (11 listed)
- Aim 1 (CD participants)
- Aim 2 (CD participants)
- Aim 2 (Control participants)
Key exclusion criteria (16 listed)
- Aim1 (CD participants)
- Aim 2 (CD participants)
- Aim 2 (Control participants)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood biomarkersbiomarkers to distinguish fibrotic vs non-fibrotic CD lesions | Diagnostic test | Aim 1 Crohn Disease participants (B2 phenotype), Aim 2 Crohn Disease participants (B1 phenotype), Aim 2 Healthy Controls |
| stool biomarkersfecal biomarkers of inflammation, mucosal inflammation | Diagnostic test | Aim 1 Crohn Disease participants (B2 phenotype), Aim 2 Crohn Disease participants (B1 phenotype), Aim 2 Healthy Controls |
| MRI imagingMRI imaging to detect bowel wall fibrosis and to detect inflamed, non-fibrotic from inflamed, fibrotic bowel | Diagnostic test | Aim 1 Crohn Disease participants (B2 phenotype), Aim 2 Crohn Disease participants (B1 phenotype) |
Primary outcome
Magnetization transfer ratio (MTR)
Time frame: Day 1
compare MTR values between Aim 1 and Aim 2 cohorts
1 secondary outcome
Correlation between MTR values and bowel wall collagen measurements
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2025.
- Individual participant dataSharing planned: No
Related trials for Crohn Disease
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonathan Dillman, MD, MSc principal investigator
Children's Hospital Medical Center, Cincinnati
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Children's Hospital Medical Center, Cincinnati at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 13 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetization transfer ratio (MTR) (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jun 2025.