Clinical trial NCT04088773: Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease
Official title: Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Crohn Disease
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: The Leona M. and Harry B. Helmsley Charitable Trust
First posted: 2019-09-13
Enrollment: 232
Sex: ALL
Minimum age (years): 8
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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

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.

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).

Eligibility 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.

Primary outcomes:
measure: Magnetization transfer ratio (MTR)
timeFrame: Day 1
Secondary outcomes:
measure: Correlation between MTR values and bowel wall collagen measurements
timeFrame: Day 1
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory/Children's Healthcare of Atlanta
state: Georgia
city: Ann Arbor
country: United States
facility: Michigan Medicine
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Jonathan Dillman, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References: