A Study To Identify Biomarkers Of Intestinal Fibrosis In Small Bowel Crohn's Disease
Overview
Tab Title Description
Study type
ObservationalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 19-005613
NCT ID: NCT04088773
Sponsor Protocol Number: 2019-0677
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 |
|
Rochester, Minn.
Mayo Clinic principal investigator David Bruining, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available