Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 8 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04088773
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Children's Hospital Medical Center, Cincinnati
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Jonathan Dillman, MD, MSc
Principal Investigator Affiliation Children's Hospital Medical Center, Cincinnati
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

OtherOther
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Additional Details

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).

Arms & Interventions

Arms

: 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

Diagnostic Test: - blood biomarkers

biomarkers to distinguish fibrotic vs non-fibrotic CD lesions

Diagnostic Test: - stool biomarkers

fecal biomarkers of inflammation, mucosal inflammation

Diagnostic Test: - MRI imaging

MRI imaging to detect bowel wall fibrosis and to detect inflamed, non-fibrotic from inflamed, fibrotic bowel

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Emory/Children's Healthcare of Atlanta, Atlanta, Georgia

Status

Recruiting

Address

Emory/Children's Healthcare of Atlanta

Atlanta, Georgia, 30322

Site Contact

Research Coordinator

holoyed@emory.edu

513-636-9403

Michigan Medicine, Ann Arbor, Michigan

Status

Recruiting

Address

Michigan Medicine

Ann Arbor, Michigan, 48109

Site Contact

Research Coordinator

ilajm@med.umich.edu

513-636-9403

Mayo Clinic, Rochester, New York

Status

Recruiting

Address

Mayo Clinic

Rochester, New York, 14625

Site Contact

Research Coordinator

becker.brenda1@mayo.edu

513-636-9403

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229

Site Contact

Research Coordinator

rebecca.imbus@cchmc.org

513-636-9403

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. For a full description of terms please refer to our Terms, Conditions & Privacy.