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

NCT ID: NCT02069561

Last Updated: 2015-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 25 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31

Brief 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.

Conditions

Ulcerative Colitis

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Eicosapentaenoic Acid

Subjects with long-standing ulcerative colitis and meeting the inclusion criteria will receive 2 g/day of Eicosapentaenoic Acid as a supplement for 90 days

Group Type: EXPERIMENTAL

Eicosapentaenoic Acid

Intervention Type: DIETARY_SUPPLEMENT

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.

Normal controls

Five patients undergoing screening colonoscopy and polypectomy using biopsy forceps. Six biopsies of healthy mucosa will be collected at the time of colonoscopy. Faeces, urine and blood samples will be collected prior to performing colonoscopy. The samples will serve as healthy reference for the basic studies.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

ALFA ™

Eligibility Criteria

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.

• Subjects undergoing screening colonoscopy within the regional colorectal cancer screening programme
• Signed informed consent
• Polypectomy with biopsy forceps.

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

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

IRCCS Azienda Ospedaliero-Universitaria di Bologna

OTHER

Sponsor Role: lead

Responsible Party

Luigi Ricciardiello

Associate Professor of Gastroenterology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Luigi Ricciardiello, MD

Role: PRINCIPAL_INVESTIGATOR

Azienda Ospedaliero Universitaria Policlinico S.Orsola Malpighi

Locations

Azienda Ospedaliero Universitaria Policlinico Sant'Orsola Malpighi

Bologna, BO, Italy

Countries

Italy

Other Identifiers

EPAUC/2013

Identifier Type: -

Identifier Source: org_study_id