NCT02069561已完成不适用
Effects of Eicosapentaenoic Acid on Molecular, Metabonomics and Intestinal Microbiota Changes, in Subjects With Long-standing Inflammatory Bowel Disease
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 2
- 主要终点
- Changes of apoptosis
研究概览
简要总结
The aim of this study is to test Eicosapentaenoic acid's effects on markers relevant to colorectal carcinogenesis, RNA and DNA profiles, and the possibility that Eicosapentaenoic Acid treatment might be associated with changes of the gut microbiota and metabolomic profiles in patients with long-standing ulcerative colitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with ulcerative colitis (diagnosed based on clinical criteria, endoscopic and histological) lasting over 8 years, with no clinical activity (SCCAI = 0), and in stable treatment (without any change in treatment in the previous 3 months) with mesalamine, immunomodulators and / or biologics.
- •Baseline fecal calprotectin> 150 micrograms / g.
- •Signed informed consent.
排除标准
- •Patients receiving systemic steroids in the two months prior to study entry.
- •Patients taking concomitant warfarin or other blood thinners.
- •Known or suspected hypersensitivity to eicosapentaenoic acid/omega
- •Women who are pregnant or of childbearing age who do not accept the use of contraceptive methods specified in the study (oral contraception, IUDs) and breastfeeding women.
- •Patients with severe medical conditions that, in the opinion of the investigator, contraindicate the patient's participation in the study.
- •Changes of treatments and / or use of experimental drugs within 3 months before inclusion in the study.
- •Use of Probiotics
- •Arm: no intervention
- •Inclusion criteria
- •Subjects undergoing screening colonoscopy within the regional colorectal cancer screening programme
- •Signed informed consent
- •Polypectomy with biopsy forceps.
- •Exclusion criteria
- •HBV-positive, HCV-positive, HIV-positive or otherwise affected by infectious diseases
- •Subjects undergoing chemo and radiation therapy within six months prior to surgery
- •Patients receiving systemic steroid in the two months prior to study entry
- •Patients undergoing antibiotic therapy within three months prior to the study
- •Patients treated with probiotics
结局指标
主要结局
Changes of apoptosis
时间窗: baseline and 3 months
Changes of RNA profiles (gene expression and micro RNA) from baseline
时间窗: baseline and at 3 months
Changes of DNA methylation profiles
时间窗: baseline and 3 months
Changes in cell proliferation
时间窗: baseline and 3 months
次要结局
- Changes of metabolomic profiles from baseline(baseline and 3 months)
- Change of Microbiota composition from baseline(baseline and 3 months)
- Changes of circulating cytokines from baseline(baseline and 3 months)
- Changes of membrane fatty acid composition from baseline(baseline and 3 months)
研究者
Luigi Ricciardiello
Associate Professor of Gastroenterology
IRCCS Azienda Ospedaliero-Universitaria di Bologna
研究点 (2)
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