Probiotics-addicted Low-protein Diet for Microbiota Modulation in Patients With Advanced Chronic Kidney Disease (ProLowCKD): a Protocol of Placebo-controlled Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change from baseline of the markers of cardiovascular diseases
研究概览
简要总结
Here the investigators will perform a double-blinded randomized placebo-controlled clinical trial to evaluate the synergic effect of low protein diet and prebiotics in reducing the microbial inflammatory uremic toxins.
详细描述
ProLowCKD is a single-centre, double-blind, placebo-controlled, randomised study. At enrolment (T0) participants were prescribed a LPD in addition to their ongoing pharmacological therapy and according to their comorbidities; after 2 months (T2) they were randomized in accordance to a 1:1 ratio to receive probiotics or placebo for other 3 months (T5) in addition to the continuation of LPD. Enrolled subjects are invited to assume two doses of probiotic/placebo for 1 month and 1 dose for 2 months.
Randomization is 1:1 to receive odd- or even envelopes, according to the odd- or even registration number at enrolment.
Neither the clinician nor the patient knows the content of the odd- and even envelopes.
The evaluations will be performed according to the following schedule: at T0 nephrological evaluation and biochemical analysis, dietary counselling, illustration of protocol and signing of the informed consent, administration of the SF36 questionnaire, body composition evaluation by bioimpedentiometry. At T0, T2, T5: blood biochemical parameters: haemoglobin, urea, creatinine, mean urea and creatinine clearance, CKD and MDRD calculation, sodium, potassium, uric acid, calcium, phosphate, PTH, acid-base balance, CRP, albumin, PC, IS, Lp-PLA2, LPS; 24h-urine biochemical parameters: urea, creatinine, sodium, proteins; microbial stools analysis; clinical nephrological and dietitian evaluation.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age 18-80 years
- •GFR < 20 ml/min/sqm
- •afferent to the outpatient clinic in the Nephrology and Dialysis Unit (Azienda Ospedaliero Universitaria Maggiore della Carità)
- •Drop out or
排除标准
- •subject refusing to sign the informed consent
- •administration of prolonged antibacterial therapy
- •dialysis initiation
结局指标
主要结局
Change from baseline of the markers of cardiovascular diseases
时间窗: 5 months
Change from baseline of the serum concentration of Lp-PLA2 (nmol/ml/min)
Change from baseline of the microbial inflammatory uremic toxins
时间窗: 5 months
Change from baseline of the serum concentration of PC (mcMOL) and IS (mcMOL), as markers of dysbiotic microbiota
Change from baseline of the markers of intestinal barrier permeability
时间窗: 5 months
Change from baseline of the serum concentration of LPS (EU/ml)
Change from baseline of the microbial gut populations
时间窗: 5 months
* Change from baseline of the concentration of proteolytic microbial groups (number of cells/gram of faeces); * Change from baseline of the concentration of saccharolytic microbial groups (number of cells/gram of faeces)
次要结局
- Measurement of the urine protein excretion(5 months)
- Evaluation of the serum acid-base equilibrium(5 months)
- Evaluation of the renal function(5 months)
- Measurement of vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning and mental health (Quality of Life)(5 months)
- Evaluation of the anemia(5 months)
- Evaluation of the body composition(5 months)
- Quantification of serum inflammatory markers(5 months)