Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 5:01 AM
Ignite Modification Date:
2025-12-25 @ 5:01 AM
NCT ID:
NCT03496818
Eligibility Criteria:
Inclusion criteria (experimental group):
1. Age 18-80 year's old.
2. Diagnosed with Crohn's disease.
3. Active small bowel Crohn's disease on MR enterography or CT enterography confirmed within the prior 30 days.
4. Inflammatory markers (eg.,. CRP, ESR) elevated above the upper limit of normal.
5. Ability to provide informed consent.
Inclusion criteria (control group):
1. Age 18-80 years old.
2. Ability to provide informed consent.
3. No diagnosis of inflammatory bowel disease.
Inclusion criteria (inflammatory arthritis or skin inflammation group):
1. Age 18-80 years old.
2. Ability to provide informed consent.
3. Taking a biologic targeting TNF (infliximab, adalimumab) for at least 4 weeks.
Exclusion Criteria
1. A history of diabetes mellitus.
2. A history of hyperlipidemia.
3. A history of thyroid dysfunction.
4. A history of hepatic, cardiac, renal or endocrine dysfunction.
5. A history of cancer requiring systemic chemotherapy
6. Prior radiation therapy to pelvis or abdomen
7. Taking medications (current or past 30 days) known to alter plasma lipid levels including statins, corticosteroids (oral, IV or topical), bile acid sequestrants, thyroid drugs, or fibrates.
8. Currently pregnant or trying to become pregnant.
9. History of abdominal or pelvic surgery.
10. Complicated small bowel CD with obstruction, penetrating disease and/or abscess.
11. Recent surgery of any type within the last 30 days that, in the discretion of the principal investigator, might affect the study or pose risk to the subject
Exclusion for control group: all of the above and no recent participation in other studies as a control.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03496818
Study Brief:
Protocol Section:
NCT03496818