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Active, Not Recruiting

NCT Number: NCT04088773

Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

8 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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
  • 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

Exclusion criteria

  • 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.
  • 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.

Treatment and study plan

Blood Biomarkers

Diagnostic Test

biomarkers to distinguish fibrotic vs non-fibrotic CD lesions

stool biomarkers

Diagnostic Test

fecal biomarkers of inflammation, mucosal inflammation

MRI imaging

Diagnostic Test

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

Primary outcomes

  1. Magnetization transfer ratio (MTR)

    Time frame: Day 1

    compare MTR values between Aim 1 and Aim 2 cohorts

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Collaborators

  • The Leona M. and Harry B. Helmsley Charitable Trust

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2026
First posted
Sep 13, 2019
Registry last updated
Jun 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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