XUANRO4 - NATURE 3.2 - Nuovo Approccio Per la Riduzione Delle Tossine Uremiche Renali, REGIONE PUGLIA - FSC 2007-2013 Ricerca. Intervento "Cluster Tecnologici Regionali"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Change of serum concentration of pCS
研究概览
简要总结
The objective of the pilot study is to validate a combined approach based on the use of an innovative symbiotic and an innovative dialysis cartridge in patients on hemodialysis (HD).
The symbiotic consists of a mixture of probiotics (Lactobacilli and Bifidobacteria), prebiotics (fructoligosaccharides and inulin) and natural antioxidants (a mix of quercetin, resveratrol and proanthocyanidins).
The cartridge is composed of a divinylbenzene (DVB) adsorbing resine, expected to have high affinity to protein-bound uremic toxins pCS and IS, on the basis of its chemical structure.
This combined approach will be aimed at achieving two main objectives:
- reduction of blood levels of microbial-derived uremic toxins, involved in cardiovascular complications
- reduction of inflammation markers and oxidative stress and reduction of intestinal permeability
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CKD patients on bicarbonate hemodialysis
- •Aged between 30 to 65
- •BMI between 18.5 and 29.9
- •Omnivore diet
- •Informed consent signed
排除标准
- •Use of antibiotics or probiotics up to 30 days prior to recruitment
- •Chronic gastrointestinal disorders
- •Systemic inflammatory diseases
- •Suspicion or clinical diagnosis of malignancy
- •Chronic liver disease
- •Treatment with corticosteroids or immunosuppressive drugs
- •Psychiatric conditions reducing the compliance to treatment protocols
研究组 & 干预措施
Symbiotic
HD patients with 7 weeks symbiotic administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge
干预措施: Symbiotic (Dietary Supplement)
Symbiotic
HD patients with 7 weeks symbiotic administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge
干预措施: DVB cartridge (Device)
Placebo
HD patients with 7 weeks placebo administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge
干预措施: DVB cartridge (Device)
Placebo
HD patients with 7 weeks placebo administration + 1 week overlapping with the 3 dialytic sessions with the DVB cartridge
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change of serum concentration of pCS
时间窗: 8 weeks
Change of p-cresyl sulfate (pCS) serum concentrations assessed by liquid chromatography/mass spectrometry
次要结局
- Change of serum concentration of D-lactate(8 weeks)
- Change of serum concentration of inflammatory markers(8 weeks)
- Change of serum concentration of LPS(8 weeks)
- Change of serum concentration of NO(8 weeks)
- Change of serum concentration of IS(8 weeks)