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 @ 4:07 AM
Ignite Modification Date:
2025-12-25 @ 4:07 AM
NCT ID:
NCT05581420
Eligibility Criteria:
Inclusion Criteria:
* Established IBD diagnosis (Crohn's disease, ulcerative colitis, IBD-unclassified)
* Adults (≥18 years of age)
* Any single Hb level between 6,2 - 7,3 mmol/L (females) 6,2 - 8,0 mmol/L (males)
* Any single ferritin \<100 μg/L and transferrin saturation \<20% within 4 weeks of study inclusion
* CRP \> 5 mg/L and / or fecal calprotectin \> 150 within 4 weeks of randomization
* Patients on immunosuppressive medication (thiopurine, methotrexate, biologicals, JAK inhibitor) for at least 8 weeks or if prednisone, for at least 2 weeks
* Mild to moderate disease according to the treating physician; a Physician Global Assessment (PGA) score of 1 or 2
* Documented informed consent
Exclusion Criteria:
* Anemia due to reasons other than iron deficiency or chronic disease (e.g. hemoglobinopathy).
* Severe disease with a PGA score of 3
* IBD patients with a location of IBD at other places than ileum and / or colon (according to treating physician)
* Patients who are prescribed PPI
* Earlier significant side effect of oral iron or iv iron
* Folic acid deficiency (\<2.5 μg/ml)
* Vitamin B12 deficiency (\<150 mg/l)
* Patients can proceed with their regular diet, but during the study they cannot take supplements that contain iron. For example, commercial vitamins with iron or a well-known iron supplement Floradix®. Intake of said supplements must be stopped at the moment of inclusion.
* Documented history of bariatric surgery or gastric/duodenal resections due to benign or malignant pathologies
* Documented major operation (e.g., laparotomy) less than six weeks before inclusion
* Documented history of liver cirrhosis, heart failure, hemoglobinopathies, autoimmune hemolytic anemia, myelodysplastic syndrome, or chronic obstructive pulmonary disease (COPD)
* Documented history of recent treatment for a malignancy (excluding dermatological malignancies such as basal cell carcinoma or squamous cell carcinoma). Patients can be included if the treatment for malignancy has been finalized ≥6 months before the inclusion date.
* End-stage renal disease (impaired renal function, defined as eGFR \<30 ml/min/1.73m2)
* Documented pregnancy or breastfeeding at the time of inclusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05581420
Study Brief:
Protocol Section:
NCT05581420