Effect of 2 Doses of EPA on Apoptosis and Cell Proliferation on Colon Mucosa

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine the effect of two doses purified EPA (an omega-3 fatty acid), on apoptosis (natural cell death) and cell proliferation (formation of new cells) in the lining of the colon for patients with a history of colonic polyps.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: S.L.A. Pharma AG

Criteria

Inclusion Criteria:

• Males or females aged over 18

• Patients of child-bearing potential must demonstrate a negative pregnancy test at screening, and should use a reliable form of contraception during the trial and for 1 month afterwards, e.g:

• Oral contraceptive + condom

• Intra-uterine device (IUD)+ condom

• Diaphragm with spermicide + condom

• Male partners of women of child bearing potential should use a reliable form of contraception during the trial and for 1 month afterwards, e.g:

• Oral contraceptive + condom

• Intra-uterine device (IUD)+ condom

• Diaphragm with spermicide + condom

• Patients must have a known history of colorectal adenomata and be under clinical follow-up for these, or be found to have one or more of these at the time of colonoscopy

• Patients must have provided written informed consent to participate

Exclusion Criteria:

• Patients who are allergic to fish

• Patients who have diabetes mellitus

• Patients who are pregnant or breast-feeding

• Patients taking aspirin or other non-steroidal anti-inflammatory drugs on a regular basis

• Patients who have aspirin-sensitive asthma

• Patients suffering from haemorrhagic disorders

• Patients who are taking warfarin or other anticoagulants

• Patients who have significant abnormalities on their screening blood tests

• Patients taking lipid lowering medication

• Patients with known inflammatory bowel disease (IBD), or previously unknown IBD until discovered at the time of their colonoscopy

• Patients with gastrointestinal malabsorptive disease

• Patients belonging to a known polyposis syndrome (e.g. FAP, HNPCC)

• Patients with a previous colonic resection for colorectal cancer

• Patients who are taking other fish-oil supplements (e.g. cod liver oil) who are unwilling to stop them for the duration of the study

• Patients who are deemed mentally incompetent, or have a history of anorexia nervosa or bulimia

• Patients with a history of alcohol or drug abuse, including laxative abuse

• Patients considered by their physician unlikely to be able to comply with the protocol.

• Patients who have taken part in an experimental drug study in the preceding 2 months.