Sporadic colonic adenomata
Conditions
Interventions
Product Name: Eicosapentaenoic acid, free fatty acid
Product Code: EPA 99%
Pharmaceutical Form: Capsule, soft
Pharmaceutical form of the placebo: Capsul
Sponsors
S.L.A. Pharma (UK) Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To measure levels of apoptosis and cell proliferation in patients with a history of colonic adenomas, before and after treatment with EPA.; Secondary Objective: To measure the uptake of EPA into the colonic mucosa after treatment. To determine the safety and tolerability of EPA. To assess COX-1 and COX-2 expression in the colonic mucosa before and after treatment with EPA. ;Primary end point(s): Within-patient changes in markers of cell proliferation and apoptosis between baseline and the 3 month and 6 month timepoints will be determined and compared across the three treatment groups. | — |
Countries
Italy, United Kingdom
Outcome results
None listed