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:
2025-12-26 @ 4:02 PM
Ignite Modification Date:
2025-12-26 @ 4:02 PM
NCT ID:
NCT01523106
Eligibility Criteria:
Inclusion Criteria:
* Patients will have had previously macro- and microscopically verified Crohn's disease, as defined by traditional clinical and endoscopic standards.
* To be included, patients need to have disease which is either in remission or is mild to moderate in severity, as defined by the Harvey-Bradshaw Index Score (HBI\<16).
* In addition, patients will need to answer "yes" to the screening study entry question ("Is fatigue a signficant problem for you currently?").
Exclusion Criteria:
* Exclusion criteria will include:
* age \<18 or \>70 years
* pregnancy or delivery within 6 months
* malignancy diagnosed within 1 year
* oral/intravenous steroid treatment within 6 months
* any surgery within 6 months
* presence of a stoma or ileo-anal J-pouch anastomosis
* concurrent hepatitis B or C infection
* cirrhosis
* renal insufficiency (CrCl\<60) and history of seizure disorder or hypothyrodism.
* prior to study enrollment
* women of child-bearing age will need to undergo pregnancy testing.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT01523106
Study Brief:
Protocol Section:
NCT01523106