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 @ 1:39 AM
Ignite Modification Date:
2025-12-25 @ 1:39 AM
NCT ID:
NCT02349594
Eligibility Criteria:
Inclusion Criteria:
* Adult patients with Crohn's disease with previous bowel surgery, currently in remission (without the need for immunosuppressive drugs) and with a high inherent TNF-α production.
Exclusion Criteria:
* Patients with other active inflammatory / immune mediated underlying diseases
* Smoking \> 5 cigarettes a day
* Diet with \>2 portions of fatty fish (tuna, salmon, mackerel, herring, and trout) a week
* History of metabolic disorder (especially diabetes or lipid disorders)
* Crohn's disease activity, including the presence of active fistulas
* On need for medical (other than 5-aminosalicylic acid preparations) or surgical treatment for Crohn's disease activity
* Use of non-steroidal anti-inflammatory drugs or aspirin
* C-reactive protein levels of \>10 mg/l
* History of venous or arterial thrombosis
* Active malignancy
* Presence of severe pulmonary, cardiovascular, renal, liver, coagulation or hematological disease
* Pregnancy or lactation
* Age \<18 yrs
* Allergy for one of the following components: fish, chicken, eggs or soy beans
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02349594
Study Brief:
Protocol Section:
NCT02349594