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:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-24 @ 11:53 PM
NCT ID:
NCT02517151
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of Ulcerative Colitis or Crohn's Disease established at least 6 months prior to Day 1 by endoscopy and/or imaging
* At least 6 months of clinical remission (Harvey Bradshaw Index ≤5; Mayo clinical score ≤ 2)
* Therapy with mesalamine, immunosuppressors or anti-tumor necrosis factor alpha (TNFα) at stable doses for at least 3 months prior enrollment; steroids are not permitted from 6 months prior baseline
* Chronic fatigue symptoms (MFI-20\>13)
* Iron deficiency: ferritin \< 100 microg/l or \< 300 microg/l in case of Transferrin-Iron Saturation Percentage (TSAT) \<20%
* Women of childbearing potential must have a negative serum pregnancy test before enrollment.
* Able and willing to provide written informed consent
Exclusion Criteria:
* Known hypersensibility to active principle or excipients
* Pregnant or lactating women
* Clinically active IBD (Harvey Bradshaw Index \>6; Mayo clinical score \>3 or C-Reactive Protein \>2.5 mg/L
* Renal failure (eGFR\<60)
* History of adrenal insufficiency
* History of autoimmune diseases
* History of malignancies
* Depression
* Any current or recent signs or symptoms of viral infectious diseases
* Recent psycho-traumatic events
* Hemoglobin levels \< 12.5 g/dl (men) or \<11.5 g/dL (women)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02517151
Study Brief:
Protocol Section:
NCT02517151