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

Ulcerative Colitis Clinical Trial

— EPAUC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02069561
• Other study ID #: EPAUC/2013
• Status: Completed
• Phase: N/A
• First received: February 19, 2014
• Last updated: September 17, 2015
• Start date: January 2014

Study information

• Verified date: September 2015
• Source: Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Colitis, Ulcerative
• Ulcerative Colitis

Intervention

Dietary Supplement:
• Eicosapentaenoic Acid
Twenty patients with long-standing ulcerative colitis undergoing the usual colonoscopic surveillance + biopsy sampling will be recruited. At entry six extra biopsy samples will be collected from the colon. We will also collect blood (for serum, plasma and red cells isolation), urine and stools. Subjects will then receive 2 g/day of Eicosapentaenoic Acid (ALFA ™, SLA Pharma AG, Switzerland) as a supplement for 90 days. At the end of the study each subject will undergo sigmoidoscopy for the collection of 6 biopsies. Blood, urine and stools will be obtained prior to the procedure.

Locations

Country	Name	City	State
Italy	Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi	Bologna	BO

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of RNA profiles (gene expression and micro RNA) from baseline		baseline and at 3 months	No
Primary	Changes of DNA methylation profiles		baseline and 3 months	No
Primary	Changes in cell proliferation		baseline and 3 months	No
Primary	Changes of apoptosis		baseline and 3 months	No
Secondary	Changes of circulating cytokines from baseline		baseline and 3 months	No
Secondary	Changes of membrane fatty acid composition from baseline		baseline and 3 months	No
Secondary	Changes of metabolomic profiles from baseline		baseline and 3 months	No
Secondary	Change of Microbiota composition from baseline		baseline and 3 months	No