A Study to Identify Biomarkers of Intestinal Fibrosis in Small Bowel Crohn's Disease

Overview

About this study

The purpose of this study is to 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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

Aim 1 (CD participants)

Aged 8-70 years old.
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 old.
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 old.
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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location	Status	Contact
Rochester, Minn. Mayo Clinic principal investigator David Bruining, M.D.	Closed for enrollment	Contact information: Brenda Becker CCRP (507)266-0111 Brenda.Becker1@mayo.edu

Mayo Clinic Location

Status

Contact

Rochester, Minn.

Mayo Clinic principal investigator

David Bruining, M.D.

Closed for enrollment

Contact information:

Brenda Becker CCRP

(507)266-0111

Brenda.Becker1@mayo.edu

More information

Publications

Publications are currently not available

Clinical Trials