Estrogen Receptor Beta Agonists (Eviendep) and Polyp Recurrence
关键词
抽象
描述
Enrolled patients were actively ongoing the surveillance program for the follow up of polyp recurrence and progression to CRC. Eligible patients should have undergone a polypectomy since 2003, affected by multiple polyps < 10 mm or one-two adenomas < 10 mm and/or with a grade of dysplasia to make them classified at intermediate risk for CRC, and scheduled to screening colonoscopy each 3-5 years. Patients were sequentially 1:1 randomly allocated to placebo or Eviendep at baseline (T0). The dietary supplements were administered twice a day for 60 days in advance of the screening colonoscopy, thus covering approximately eight complete colon epithelial turnover to occur. Five days in advance of T60 colonoscopy, patients refrained from fresh and cooked fruit and vegetable intake. Bowel cleansing was achieved by PEG 4000 oral administration (1120 g/4 L water solution). N=8 biopsy samples/patient were collected from the non adenomatous mucosa in the sigmoidal colon. Small polyps (diameter less or equal 0.5 cm) were topically electrocoagulated, whereas villous and tubulovillous polyps (diameter equal or higher than 0.5 cm) were submitted to the histological assessment.
日期
| 最后验证: | 06/30/2011 |
| 首次提交: | 07/24/2011 |
| 提交的预估入学人数: | 07/24/2011 |
| 首次发布: | 07/25/2011 |
| 上次提交的更新: | 07/24/2011 |
| 最近更新发布: | 07/25/2011 |
| 实际学习开始日期: | 09/30/2009 |
| 预计主要完成日期: | 02/28/2011 |
| 预计完成日期: | 03/31/2011 |
状况或疾病
干预/治疗
Dietary Supplement: Eviendep (CM&D Pharma Limited, UK)
Dietary Supplement: Dietary supplement
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Placebo Comparator: Dietary supplement 900 mg Maltodextrins | Dietary Supplement: Dietary supplement 900 mg maltodextrin+excipient as per the active comparator eviendep, up to 5 g/sachet |
| Active Comparator: Eviendep (CM&D Pharma Limited, UK) 175 mg milk thistle (fruit dry extract, 70% in silymarin)+ 20 mg flaxseed (dry extract, 40% in secoisolariciresinoldiglucoside) + 750 mg non starch, insoluble and indigestible fiber (6% in lignin). | Dietary Supplement: Eviendep (CM&D Pharma Limited, UK) 175 mg milk thistle (fruit dry extract, 70% in silymarin)+ 20 mg flaxseed (dry extract, 40% in secoisolariciresinoldiglucoside)+750 mg non-starch, insoluble and indigestible fiber (6% in lignin). Provided in 5 g sachets, to be dissolved in half glass water, administered twice a day for 60 days on top of the common diet. |
资格标准
| 有资格学习的年龄 | 50 Years 至 50 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - Men and women, age: 50-70 years - Menopausal women since at least 2 years - Diagnosed since 2003 for adenomas, underwent polypectomy and histological assessment - Regularly inscribed and actively ongoing the surveillance program for the follow-up of adenoma recurrence and progression to advanced adenomas - Screening colonoscopy every 3-5 years - No previous or concomitant administration of ASA and NSAIDs - No previous or concomitant administration of Hormonal Replacement Therapy (HRT) - No previous or concomitant administration of other phytoestrogens Exclusion Criteria: - Chronic inflammatory intestinal disease - Intestinal and/or extraintestinal malignant neoplasms - Acute or chronic renal disease - Anemia - Coagulation disorders, - BMI > 30 - Systemic corticosteroids - Anticoagulants or platelet antiaggregants - Antibiotics within 30 days from enrollment |
结果
主要结果指标
1. Expression of ERβ, ERα, TUNEL, Caspase-3, Ki-67 in bioptic samples of non adenomatous mucosa in sporadic adenopolyposis [60 days following dietary oral supplementation, in advance of the screening colonoscopy as per the planning of the surveillance program]
次要成果指标
1. Safety assessed by unchanged hematochemistry [30 and 60 days following dietary oral supplementation]
2. Urinary lignans [baseline (T0, 30 (T30) and 60 (T60) days during the study period]
