Modulation of Esophageal Inflammation in Barrett's Esophagus by Omega-3 Fatty Acids, a Double Blind Placebo Controlled Randomized Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Serum PGE2 Levels
研究概览
简要总结
This study is being done to understand the effect of dietary omega-3 fats in decreasing tissue inflammation in Barrett's esophagus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo
Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive a placebo which looks exactly like the study drug, but contains no active ingredient, to be taken orally for six months.
干预措施: Placebo (Drug)
Omega-3 polyunsaturated fatty acids
Subjects with known Barrett's Esophagus (no dysplasia and low-grade dysplasia) will receive Omega-3 free fatty acids supplements to be taken orally for six months.
干预措施: Omega-3 polyunsaturated fatty acids (Drug)
结局指标
主要结局
Change in Serum PGE2 Levels
时间窗: Baseline, 6 months
Percent change from baseline to 6 months in serum prostaglandin E2 (PGE2) level obtained from blood draw
Change in Esophageal Tissue PGE2 Levels
时间窗: Baseline, 6 months
Percent change from baseline to 6 months in esophageal tissue prostaglandin E2 (PGE2) level obtained from endoscopic esophageal tissue collection
次要结局
- Change in Esophageal Macrophage Markers(Baseline, 6 months)
研究者
Prasad G. Iyer
Principal Investigator
Mayo Clinic