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 @ 1:03 PM
Ignite Modification Date:
2025-12-24 @ 1:03 PM
NCT ID:
NCT02069561
Eligibility Criteria:
Arm: experimental
Inclusion Criteria:
* Patients with ulcerative colitis (diagnosed based on clinical criteria, endoscopic and histological) lasting over 8 years, with no clinical activity (SCCAI = 0), and in stable treatment (without any change in treatment in the previous 3 months) with mesalamine, immunomodulators and / or biologics.
* Baseline fecal calprotectin\> 150 micrograms / g.
* Signed informed consent.
Exclusion Criteria:
* Patients receiving systemic steroids in the two months prior to study entry.
* Patients taking concomitant warfarin or other blood thinners.
* Known or suspected hypersensitivity to eicosapentaenoic acid/omega 3.
* Women who are pregnant or of childbearing age who do not accept the use of contraceptive methods specified in the study (oral contraception, IUDs) and breastfeeding women.
* Patients with severe medical conditions that, in the opinion of the investigator, contraindicate the patient's participation in the study.
* Changes of treatments and / or use of experimental drugs within 3 months before inclusion in the study.
* Use of Probiotics
Arm: no intervention
Inclusion criteria
* Subjects undergoing screening colonoscopy within the regional colorectal cancer screening programme
* Signed informed consent
* Polypectomy with biopsy forceps.
Exclusion criteria
* HBV-positive, HCV-positive, HIV-positive or otherwise affected by infectious diseases
* Subjects undergoing chemo and radiation therapy within six months prior to surgery
* Patients receiving systemic steroid in the two months prior to study entry
* Patients undergoing antibiotic therapy within three months prior to the study
* Patients treated with probiotics
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02069561
Study Brief:
Protocol Section:
NCT02069561