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Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04088773
Recruitment Status : Recruiting
First Posted : September 13, 2019
Last Update Posted : January 18, 2020
Sponsor:
Collaborator:
The Leona M. and Harry B. Helmsley Charitable Trust
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Crohn Disease Diagnostic Test: blood biomarkers Diagnostic Test: stool biomarkers Diagnostic Test: MRI imaging

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).

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Study Type : Observational
Estimated Enrollment : 232 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease
Actual Study Start Date : November 1, 2019
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort Intervention/treatment
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
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

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
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

Aim 2 Healthy Controls
No intervention; observational only; collection of blood, stool, and completion of Gastrointestinal Symptoms Rating Scale
Diagnostic Test: blood biomarkers
biomarkers to distinguish fibrotic vs non-fibrotic CD lesions

Diagnostic Test: stool biomarkers
fecal biomarkers of inflammation, mucosal inflammation




Primary Outcome Measures :
  1. Magnetization transfer ratio (MTR) [ Time Frame: Day 1 ]
    compare MTR values between Aim 1 and Aim 2 cohorts


Secondary Outcome Measures :
  1. Correlation between MTR values and bowel wall collagen measurements [ Time Frame: Day 1 ]
    combine all subjects from Aim 1 and Aim 2 that undergo MRI



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04088773


Contacts
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Contact: Becky Imbus 513-636-9403 rebecca.imbus@cchmc.org

Locations
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United States, Georgia
Emory/Children's Healthcare of Atlanta Recruiting
Atlanta, Georgia, United States, 30322
Contact: Research Coordinator       holoyed@emory.edu   
Principal Investigator: Subra Kugathasan, MD         
United States, Michigan
Michigan Medicine Recruiting
Ann Arbor, Michigan, United States, 48109
Contact: Research Coordinator       ilajm@med.umich.edu   
Principal Investigator: Ryan Stidham, MD, MSc         
United States, New York
Mayo Clinic Recruiting
Rochester, New York, United States, 14625
Contact: Research Coordinator       becker.brenda1@mayo.edu   
Principal Investigator: David Bruining, MD         
United States, Ohio
Cincinnati Children's Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact: Research Coordinator       rebecca.imbus@cchmc.org   
Principal Investigator: Jonathan Dillman, MD, MSc         
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
The Leona M. and Harry B. Helmsley Charitable Trust
Investigators
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Principal Investigator: Jonathan Dillman, MD, MSc Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT04088773    
Other Study ID Numbers: 2019-0677
First Posted: September 13, 2019    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases