NCT03265639已完成不适用
Prebiotics in Peritoneal Dialysis
Ali Ramezani4 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2016年4月21日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 9
- 试验地点
- 4
- 主要终点
- Change within-patient in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phases and the p-inulin treatment phase.
研究概览
简要总结
The Prebiotics in Peritoneal Dialysis trial is a non-randomized, open-label, crossover study of p-inulin for patients with end-stage renal disease treated with peritoneal dialysis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
盲法说明
Open label
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Peritoneal dialysis therapy for end-stage renal disease
- •≥30 days since dialysis initiation
- •Ability to provide informed consent
排除标准
- •Use of pre- or pro-biotics during the past 2 months
- •Consumption of pro-biotic yogurt during the past 2 weeks
- •Use of antibiotics within the past 2 months
- •Presence of chronic infection
- •Chronic gastrointestinal condition other than constipation
- •Cirrhosis or chronic active hepatitis
- •Stomach/intestinal resection
- •PD access problems
- •Anticipated kidney transplant or transfer to another dialysis unit within 9 months
- •Expected survival < 9 months
- •Pregnancy, anticipated pregnancy, or breastfeeding
- •Incarceration
- •Participation in another intervention study
- •Severe anemia defined as hemoglobin <9.0 g/dl
研究组 & 干预措施
Pre-treatment
No Intervention
This arm is the 8-week observation period before the p-inulin treatment phase.
Intervention
Experimental
This arm is the 8 week p-inulin treatment phase (8 grams twice daily, oral).
干预措施: P-inulin (Dietary Supplement)
Post-treatment
No Intervention
This arm is the 8-week observation period after the p-inulin treatment phase.
结局指标
主要结局
Change within-patient in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phases and the p-inulin treatment phase.
时间窗: 24 weeks
Metabolomic Profile: the relative abundance of metabolites, determined by liquid chromatography-mass spectrometry (LC-MS), will be quantified under each condition and compared between groups.
次要结局
- Within-patient variability in the bacterial composition of the stool during the no treatment phase.(24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation))
- Within-patient variability in the bacterial composition of the stool during the p-inulin treatment phase.(24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation))
- Within-patient change in the bacterial composition of the stool after p-inulin treatment compared with pre-treatment(24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation))
- Within-cohort variability in the metabolomic profile and targeted metabolites / inflammatory markers during the no treatment phase.(24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation))
- Within-cohort variability in the bacterial composition during the no treatment phase.(24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation))
- Within-patient change in the metabolomic profile and targeted metabolites / inflammatory markers after p-inulin treatment compared with pre-treatment.(24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation))
- Within-cohort change in the bacterial composition after p-inulin treatment compared with pre-treatment.(24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation))
- Within-cohort variability in the metabolomics profile and targeted metabolites/inflammatory markers during the p-inulin treatment phase.(24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation))
- Within-cohort variability in the bacterial composition during the p-inulin treatment phase.(24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation))
- Within-cohort change in the metabolomic profile and targeted metabolites/inflammatory markers after p-inulin treatment compared with pre-treatment(24 weeks (8 week period of observation, 8 week period of treatment, 8 week period of observation))
研究者
Ali Ramezani
Assistant Research Professor
George Washington University
研究点 (4)
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