Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease

Crohn Disease Clinical Trial

Official title:

Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04088773
• Other study ID #: 2019-0677
• Status: Active, not recruiting
• Start date: November 1, 2019
• Est. completion date: September 2024

Study information

• Verified date: September 2023
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 232
• Est. completion date: September 2024
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease

Intervention

Diagnostic Test:
• 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

Locations

Country	Name	City	State
United States	Michigan Medicine	Ann Arbor	Michigan
United States	Emory/Children's Healthcare of Atlanta	Atlanta	Georgia
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati	The Leona M. and Harry B. Helmsley Charitable Trust

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Magnetization transfer ratio (MTR)	compare MTR values between Aim 1 and Aim 2 cohorts	Day 1
Secondary	Correlation between MTR values and bowel wall collagen measurements	combine all subjects from Aim 1 and Aim 2 that undergo MRI	Day 1