At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Two-Arm Chemoprevention Trial in Familial Adenomatous Polyposis (FAP) Coli Patients Using the Purified Free Fatty Acid, Eicosapentaenoic Acid
In Brief
A Phase 3 clinical trial evaluating Eicosapentanoic Acid (EPA), Endoscopy, and 2 other interventions for Familial Adenomatous Polyposis Coli and FAP. Completed, enrolled 58 participants across 1 site.
Detailed Summary
This purpose of this study is to investigate whether the number and size of rectal polyps can be reduced in patients with Familial Adenomatous Polyposis (FAP) by using a highly-purified form of a naturally occurring substance, the omega-3 fatty acid, eicosapentaenoic acid (EPA).
Study Details
Timeline
Interventions
2 x 500mg EPA capsules twice daily for 6 months
Endoscopy with video and photographs at baseline and month 6.
9 biopsies taken at baseline and month 6 from the rectum of normal mucosa for analysis of apoptosis (3 biopsies), cell proliferation (3 biopsies) and mucosal fatty acid levels (3 biopsies). Two biopsies taken at baseline and month 6 from polyps for cell proliferation (1 biopsy) and apoptosis (1 biopsy).
2 x 500mg placebo capsules twice daily for 6 months