NCT01186276已完成不适用
Dietary Maneuvers to Reduce Production of Colon-Derived Uremic Solutes
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 6
- 主要终点
- Plasma level of p-cresol sulfate
研究概览
简要总结
This study will assess whether dietary fiber supplements can reduce the production of chemicals which are produced by colon bacteria and normally excreted from the body by the kidney, but build up in the body in patients on hemodialysis.
详细描述
The study procedures will consist of:
- taking a dietary supplement containing either fiber or starch (starch serves as a control for fiber) for six weeks. The fiber dose initially employed will be 30 g/day of high amylose corn and the control starch dose employed will be 30 g/day of waxy corn starch. Supplements which come in dry powder form will be mixed in liquid or food for consumption.
- filling out a food record and a quality of life questionnaire
- keeping a diary of any gi symptoms
- collecting samples of blood, spent dialysate, urine(if the patient still makes urine) and stool.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •stable dialysis patients able to provide consent.
排除标准
- •- known g.i. disease
- •use of antibiotics for the last two month or expected antibiotic use
- •recent hospitalization or other event resulting in instability of food intake
结局指标
主要结局
Plasma level of p-cresol sulfate
时间窗: 8 weeks
次要结局
- Caloric intake(8 weeks)
研究者
研究点 (6)
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