XUANRO4 - NATURE 3.1 - 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
- 50
- 试验地点
- 1
- 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 the clinical use of an innovative symbiotic in patients with chronic kidney disease (CKD) stage 3b-4 and in healthy subjects.
The study aims at evaluating the effects of a symbiotic, consisting of a mixture of probiotics (Lactobacilli and Bifidobacteria), prebiotics (fructooligosaccharides and inulin) and natural antioxidants (a mix of quercetin, resveratrol and proanthocyanidins), by achieving two objectives:
- Reduction of the serum levels of microbiota-derived uremic toxins, involved in a variety of cardiovascular complications in CKD
- Reduction of intestinal permeability, inflammatory markers and oxidative stress
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
- 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
- 是
入选标准
- •CKD patients
- •Inclusion Criteria:
- •CKD patients stage 3b-4 not on dialysis
- •Aged between 30 to 65
- •BMI between 18.5 and 29.9
- •Controlled diet
- •Informed consent signed
排除标准
- •Type 2 diabetes mellitus
- •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
- •Previous acute cardiovascular diseases (myocardial infarction, stroke)
- •Psychiatric conditions reducing the compliance to treatment protocols
- •Healthy volunteers
- •Inclusion Criteria:
- •Healthy subjects
- •Aged between 35 to 60
- •BMI between 18.5 and 29.9
- •Medium score of adherence to Mediterranean Diet (PREDIMED score between 6 and 9)
- •Informed consent signed
- •Exclusion Criteria:
- •Type 2 diabetes mellitus
- •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
- •Previous acute cardiovascular diseases (myocardial infarction, stroke)
- •Psychiatric conditions reducing the compliance to treatment protocols
研究组 & 干预措施
CKD patients
CKD patients stage 3b-4 will follow a 2-months supplementation of either symbiotic or placebo
干预措施: Symbiotic (Dietary Supplement)
CKD patients
CKD patients stage 3b-4 will follow a 2-months supplementation of either symbiotic or placebo
干预措施: Placebo (Dietary Supplement)
Controls
Healthy volunteers will follow a 2-months supplementation of either symbiotic or placebo
干预措施: Symbiotic (Dietary Supplement)
Controls
Healthy volunteers will follow a 2-months supplementation of either symbiotic or placebo
干预措施: Placebo (Dietary Supplement)
结局指标
主要结局
Change of serum concentration of pCS
时间窗: 3 months
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(3 months)
- Change of serum concentration of IS(3 months)
- Change of serum concentration of LPS(3 months)
- Change of percentage of sugar urinary recovery(3 months)
- Change of serum concentration of inflammatory markers(3 months)
- Change of serum concentration of NO(3 months)