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Effects of Eicosapentaenoic Acid on Subjects at High Risk for Colorectal Cancer

Information source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Ulcerative Colitis

Intervention: Eicosapentaenoic Acid (Dietary Supplement)

Phase: N/A

Status: Recruiting

Sponsored by: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Official(s) and/or principal investigator(s):
Luigi Ricciardiello, MD, Principal Investigator, Affiliation: Azienda Ospedaliero Universitaria Policlinico S.Orsola Malpighi

Overall contact:
Luigi Ricciardiello, MD, Phone: +393669614317, Email: luigi.ricciardiello@unibo.it

Summary

The aim of this study is to test Eicosapentaenoic acid's effects on markers relevant to colorectal carcinogenesis, RNA and DNA profiles, and the possibility that Eicosapentaenoic Acid treatment might be associated with changes of the gut microbiota and metabolomic profiles in patients with long-standing ulcerative colitis.

Clinical Details

Official title: Effects of Eicosapentaenoic Acid on Molecular, Metabonomics and Intestinal Microbiota Changes, in Subjects With Long-standing Inflammatory Bowel Disease

Study design: Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Primary outcome:

Changes of RNA profiles (gene expression and micro RNA) from baseline

Changes of DNA methylation profiles

Changes in cell proliferation

Changes of apoptosis

Secondary outcome:

Changes of circulating cytokines from baseline

Changes of membrane fatty acid composition from baseline

Changes of metabolomic profiles from baseline

Change of Microbiota composition from baseline

Eligibility

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Locations and Contacts

Luigi Ricciardiello, MD, Phone: +393669614317, Email: luigi.ricciardiello@unibo.it

Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi, Bologna, BO 40138, Italy; Recruiting
Luigi Ricciardiello, MD, Phone: +393669614317, Email: luigi.ricciardiello@unibo.it
Luigi Ricciardiello, MD, Principal Investigator
Additional Information

Starting date: January 2014
Last updated: June 24, 2015

Page last updated: August 23, 2015

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