The effect of two dose levels of eicosapentaenoic acid (EPA) on apoptosis and cell proliferation in the colonic mucosa of patients with a history of colonic polyps.

S.L.A. Pharma (UK) Ltd0 个研究点目标入组 140 人开始时间: 2006年5月16日最近更新: 2019年11月25日

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•To qualify for inclusion in this study, the participant must satisfy all of the criteria listed below:
•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.
•Male partners of women of child bearing potential should use a reliable form of contraception during the trial and for 1 month afterwards.
•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
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•The patient will be excluded from the study for any of the following reasons:
•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

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S.L.A. Pharma (UK) Ltd