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临床试验/NCT05019599
NCT05019599Unknown不适用

Exploring the Role of Low Protein Diet on the Gut Microbiome, Related Metabolites and Renal Function in Chronic Kidney Disease

Chang Gung Memorial Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年8月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
change of gut microbiota

研究概览

简要总结

Chronic kidney disease (CKD) is a worldwide public health dilemma because of close association with multiple comorbidities, demanding high cardiovascular events, mortality and expensive medical cost. Novel and effective therapeutic measures remain urgently needed to reduce burden and impact of disease. Advanced renal failure can profoundly alter the biochemical milieu of the gastrointestinal tract leading to a leak gut. Application of 16s rRNA gene analysis identified an increase of Clostridia, Actinobacteria, and Gammaproteobacteria in hemodialysis patients and decrease of Bifidobacterium and lactobacillus in peritoneal patients. This altered microbiome consequently affect production of indole or phenol derived uremic toxins leading to renal damage. Our preliminary results indicated reduced number and diversity of intestinal microbes CKD patients compared to normal. Different dietary nutrients can affect the gut microbiome and derive several deleterious metabolites leading to metabolic disarrangement. Clinically, low-protein diet should be prescribe to renal patients to preserve renal function and high fat content are usually recommended to avoid caloric malnutrition to dietary restriction. The changes of diet-microbiome-metabolite interaction are large unknown with this dietary manipulation. The aims of this study is to determine the renal progression-associated gene and taxonomic alterations bymetagenome-wide association studies and the functional characterization of gut microbiome in CKD patients receiving different low-protein or high-fat diets. The results of the study will provide insight on the exact role of dietary manipulation in CKD patients from gut-renal cross talk.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
30 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • . Patients aged 30-90 years with diagnosis of CKD (defined as abovementioned).
  • . Sign the inform consent and agree to participate in this study.
  • . Compliant to low protein diet (defined as protein intake <0.8 g/Kg/day) for 4 weeks assessed by 24h urine urea estimates, before enrollment

排除标准

  • . History of any malignancy, liver cirrhosis, intestinal operation, irritable bowel syndrome, cardiovascular disease (defined as myocardial infarction, documented Q wave on EKG, unstable angina, coronary artery disease with stenosis > 75%, congestive heart failure with Ejection Fraction < 50% and cerebrovascular disease) in the past 3 months.
  • . History of or infection disease requiring admission in the past 3 months or, concomitant antibiotics use.
  • . Concomitant use of probiotics or prebiotics.
  • . Pregnancy.
  • . Renal transplant recipients.

结局指标

主要结局

change of gut microbiota

时间窗: 3 months

change of relative abundance of microbes

change of host metabolite concentration

时间窗: 3 months

change of concentration of serum metabolomic profile

change of renal function

时间窗: 3 months

serum creatinine, estimated glomerular filtration rate or urine total protein

次要结局

未报告次要终点

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (2)

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