To Evaluate the Clinical Efficacy of Probiotic in Patients With DKD
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 from baseline in Cys-C (Cystatin C) level at 3 months
研究概览
简要总结
To evaluate the efficacy of probiotics in the treatment of diabetic kidney disease, this study is designed to explore after consumption of probiotics lactobacillus reuteri ADR-1 and lactobacillus rhamnosus GM-020 composite strain powder sachets for 6 months, whether the improvement of blood sugar, kidney related indicators can further improve the course of diabetic kidney disease. The clinical trial predicted that probiotics can improve diabetic kidney disease by changing the intestinal flora by inhibiting harmful bacteria, reduction of systemic oxidative stress, balance carbohydrate and fat metabolism, further preventing the progress of diabetic kidney disease.
详细描述
WHO predicts that diabetes will become the seventh leading cause of death in 2030. This disease usually causes complications including hypertension, diabetic kidney disease, neuropathy, skin infection, and a high risk of blindness and so on. It demonstrated that probiotics have beneficial effects on several disorders; these beneficial effects include a reduction in allergic symptoms, a decrease in serum cholesterol levels, the prevention of obesity, and an improvement of the digestive system. In recent years, many studies have pointed out that Lactobacillus affects the progression of diabetes kidney disease by controlling blood sugar. From 2017 to 2020, 8 clinical trials conducted related research to explore the clinical benefits of probiotics on diabetic kidney disease. It was found that the indicators related to kidney function have ameliorated significantly, including improving glomerular function, blood sugar control, insulin metabolism, inflammatory substances in serum, and even oxidative stress factors, etc.
In a previous study, Lactobacillus strain ADR-1 was selected to verify the efficacy by utilizing HFD (High-fructose-fed) rats model, the result shows reductions in serum HbA1c and liver injury after oral gavage for 14 weeks. Afterward, a double-blind, randomized, placebo-group human clinical trial was conducted, recruiting 68 subjects with type 2 diabetes to evaluate the intestinal flora and blood sugar-related indicators, among which the metabolic indicators had significant changes. After taking it for 3 and 6 months, HbA1c and cholesterol were significantly reduced compared to the Placebo group, it was also found that the L.reuteri flora had a significant increase in the intestinal flora while the same pattern was found in the Bifidobacterium flora accordingly. This result represents the development of a positive correlation between Lactobacillus and Bifidobacterium for the intestinal flora. Furthermore, GM-020 has been proved by mouse model experiments to slow down kidney diseases, including the improvement of related indicators of renal function, serum urea nitrogen (BUN), and creatinine (Creatinine), and it shows dose-dependent variation. The combination of these two strains of probiotics is predicted to improve the metabolical index of diabetic kidney disease.
This clinical trial will explore the health-promoting effect of probiotics on patients with diabetic kidney disease, and fully explore how probiotics can improve the good bacteria and reduce the bad bacteria by changing the intestinal flora to achieve anti-inflammatory effects, Chronic inflammation, reduce systemic oxidative stress, balances carbohydrate and fat metabolism, and prevents the progression of diabetic kidney disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 25 and 80 years old
- •Suffering from type 2 diabetes and stable medication for 3 months
- •Detection of HbA1c before meals between 7% and 10%
- •Stage 1-3a diabetic nephropathies (eGFR > 45 mL/min)
- •Microalbuminuria estimated between 30 to 300 mg/day
排除标准
- •Patients with Type I Diabetes Mellitus
- •Patients with inflammatory bowel disease, liver disease, liver cirrhosis, systemic lupus erythematosus, malignancy, and high blood pressure.
- •Patients with hypoglycemic coma, Diabetic ketoacidosis, hyperosmolar non-ketotic diabetic coma, or diabetes mellitus acute complications.
- •Acute infection medical history in past 3 month
- •Fasting blood glucose >13.3 mmol/L
- •GPT>100U/L (2.5 times than usual situation)
- •Vulnerable population (Including breeding or pregnant women, prisoner, aboriginal, disabled population)
- •Smoker or Alcoholic
- •Taking Antibiotics in past 1 month
- •Stably taking probiotics supplements in past 1 months (Yogurt or dairy products were excluded)
- •Taking immunosuppressive drug, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers in past 3 months
结局指标
主要结局
Change from baseline in Cys-C (Cystatin C) level at 3 months
时间窗: 3 months
Blood samples will be collected to examine the variation of Cys-C (Cystatin C) from baseline at 3 months.
Change from baseline in Cys-C (Cystatin C) level at 6 months
时间窗: 6 months
Blood samples will be collected to examine the variation of Cys-C from baseline at 6 months.
次要结局
- Change from baseline in self-record of the International physical activity questionary (IPAQ) in physical assessment at 6 months(6 months)
- Change from baseline in the level of GA (Glycated albumin) at 3-months(3 months)
- Change from baseline in gut microbiota at 6 months(6 months)
- Change from baseline in the level of TMAO (Trimethylamine N-oxide) at 3-months(3 months)
- Change from baseline in BMI (Body Mass Index) at 3 months(3 months)
- Change from baseline in BMI (Body Mass Index) at 6 months(6 months)
- Change from baseline in levels of HbA1c (Hemoglobin A1C) at 3-months(3 months)
- Change from baseline in the level of Urine microalbuminuria/creatinine at 3-months(3 months)
- Change from baseline in the level of Urine acid at 3-months(3 months)
- Change from baseline in the level of CG at 6-months(6 months)
- Change from baseline in levels of TIBC at 6-months(6 months)
- Change from baseline in the level of CRE at 6-months(6 months)
- Change from baseline in the level of K+ at 6-months(6 months)
- Change from baseline in blood pressure at 6 months(6 months)
- Change from baseline in levels of FPG (Fasting Plasma Glucose) at 3-months(3 months)
- Change from baseline in levels of serum insulin at 3-months(3 months)
- Change from baseline in levels of serum insulin at 6-months(6 months)
- Change from baseline in levels of HbA1c at 6-months(6 months)
- Change from baseline in levels of HOMA-IR at 6-months(6 months)
- Change from baseline in levels of HOMA-β (Homeostatic Model Assessment for β-cell function) at 6-months(6 months)
- Change from baseline in levels of QUICKI (Quantitative Insulin Sensitivity Check Index) at 3-months(3 months)
- Change from baseline in the level of GA (Glycated albumin) at 6-months(6 months)
- Change from baseline in Waist and hip circumference at 6 months(6 months)
- Change from baseline in levels of HOMA-β (Homeostatic Model Assessment for β-cell function) at 3-months(3 months)
- Change from baseline in levels of QUICKI (Quantitative Insulin Sensitivity Check Index) at 6-months(6 months)
- Change from baseline in the level of BUN at 6-months(6 months)
- Change from baseline in the level of Urine protein/albumin at 3-months(3 months)
- Change from baseline in the level of Urine acid at 6-months(6 months)
- Change from baseline in levels of blood lipid-related Index at 3 months(3 months)
- Change from baseline in the level of SCFA (Short Chain Fatty Acids) at 6 months(6 months)
- Change from baseline in Waist and hip circumference at 3 months(3 months)
- Change from baseline in blood pressure at 3 months(3 months)
- Change from baseline in levels of FPG at 6-months(6 months)
- Change from baseline in levels of HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) at 3-months(3 months)
- Change from baseline in the level of K+ (Potassium) at 3-months(3 months)
- Change from baseline in the level of CG (The Cockcroft and Gault formula) at 3-months(3 months)
- Change from baseline in levels of blood lipid-related Index at 6 months(6 months)
- Change from baseline in levels of cytokines Index at 3 months(3 months)
- Change from baseline in levels of cytokines Index at 6 months(6 months)
- Change from baseline in the level of TMAO at 6-months(6 months)
- Change from baseline in the level of CRE (Creatinine) at 3-months(3 months)
- Change from baseline in the level of BUN (Blood Urea Nitrogen) at 3-months(3 months)
- Change from baseline in the level of Urine protein/albumin at 6-months(6 months)
- Change from baseline in the level of Urine microalbuminuria/creatinine at 6-months(6 months)
- Change from baseline in the level of eGFR (Estimated Glomerular Filtration Rate) at 3-months(3 months)
- Change from baseline in the level of eGFR (Estimated Glomerular Filtration Rate) at 6-months(6 months)
- Change from baseline in levels of TIBC (Total Iron-Binding Capacity) at 3-months(3 months)