NCT02069561

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2014-01-01
• Primary completion: 2015-08-01
• First posted: 2014-02-24
• Last updated: 2015-09-18

Locations

1 site across 1 country: Italy