An interventional study of Probiotic group and Placebo group in Diabetic Kidney Disease, sponsored by GenMont Biotech Incorporation. Completed at 1 site in Taiwan. Open to participants aged 25 Years to 80 Years. Per ClinicalTrials.gov, last updated 2025-12-08.
Sponsored by GenMont Biotech Incorporation · Not applicable, Interventional, and Supportive care
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.
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.
Exclusion Criteria:
Subjects received two probiotic sachets per day
Dietary Supplement: Probiotic group
Subjects received two placebo sachets per day
Other: Placebo group
Two-strain probiotic supplement includes Lactobacillus reuteri ADR-1 (alive) and Lactobacillus rhamnosus GM-020 ( alive).
Also known as: Test group
Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.
Also known as: Control group
Change from baseline in Cys-C (Cystatin C) level at 3 months
Blood samples will be collected to examine the variation of Cys-C (Cystatin C) from baseline at 3 months.
Time frame: 3 months
Change from baseline in Cys-C (Cystatin C) level at 6 months
Blood samples will be collected to examine the variation of Cys-C from baseline at 6 months.
Time frame: 6 months
Change from baseline in BMI (Body Mass Index) at 3 months
BMI will be calculated with weight and height combined in kg/m\^2.
Time frame: 3 months
Change from baseline in BMI (Body Mass Index) at 6 months
BMI will be calculated with weight and height combined in kg/m\^2.
Time frame: 6 months
Change from baseline in Waist and hip circumference at 3 months
Waist and hip circumference will take down in centimeters.
Time frame: 3 months
Change from baseline in Waist and hip circumference at 6 months
Waist and hip circumference will take down in centimeters.
Time frame: 6 months
Change from baseline in blood pressure at 3 months
The unit of measurement of blood pressure is mmHg. Both systolic and diastolic blood pressure will be measured.
Time frame: 3 months
Change from baseline in blood pressure at 6 months
The unit of measurement of blood pressure is mmHg. Both systolic and diastolic blood pressure will be measured.
Time frame: 6 months
Change from baseline in levels of FPG (Fasting Plasma Glucose) at 3-months
Fasting blood samples will be collected to examine variation in FPG in uIU/mL.
Time frame: 3 months
Change from baseline in levels of FPG at 6-months
Fasting blood samples will be collected to examine variation in FPG in uIU/mL.
Time frame: 6 months
Change from baseline in levels of serum insulin at 3-months
Fasting blood samples will be collected to examine variation in serum insulin in uIU/mL.
Time frame: 3 months
Change from baseline in levels of serum insulin at 6-months
Fasting blood samples will be collected to examine variation in serum insulin in uIU/mL.
Time frame: 6 months
Change from baseline in levels of HbA1c (Hemoglobin A1C) at 3-months
Fasting blood samples will be collected to investigate the levels of HbA1c in %.
Time frame: 3 months
Change from baseline in levels of HbA1c at 6-months
Fasting blood samples will be collected to investigate the levels of HbA1c in %.
Time frame: 6 months
Change from baseline in levels of HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) at 3-months
The equation of HOMA-IR=(insulin (mIU/L) and glucose (mg/dL))/405)
Time frame: 3 months
Change from baseline in levels of HOMA-IR at 6-months
The equation of HOMA-IR=(insulin (mIU/L) and glucose (mg/dl))/405)
Time frame: 6 months
Change from baseline in levels of HOMA-β (Homeostatic Model Assessment for β-cell function) at 3-months
The equation of HOMA-β=20 × fasting insulin (μIU/ml)/fasting glucose (mmol/ml) - 3.5
Time frame: 3 months
Change from baseline in levels of HOMA-β (Homeostatic Model Assessment for β-cell function) at 6-months
The equation of HOMA-β=20 × fasting insulin (μIU/ml)/fasting glucose (mmol/ml) - 3.5
Time frame: 6 months
Change from baseline in levels of QUICKI (Quantitative Insulin Sensitivity Check Index) at 3-months
The equation of QUICKI=1 / \[log(Fasting Insulin (µU/ml) + log(Fasting Glucose (mg/dL))\]
Time frame: 3 months
Change from baseline in levels of QUICKI (Quantitative Insulin Sensitivity Check Index) at 6-months
The equation of QUICKI=1 / \[log(Fasting Insulin (µU/ml) + log(Fasting Glucose (mg/dL))\]
Time frame: 6 months
Change from baseline in the level of GA (Glycated albumin) at 3-months
Blood samples will be collected to examine changes in GA in mg/dL.
Time frame: 3 months
Change from baseline in the level of GA (Glycated albumin) at 6-months
Blood samples will be collected to examine changes in GA in mg/dL.
Time frame: 6 months
Change from baseline in the level of CRE (Creatinine) at 3-months
Blood samples will be collected to examine changes in CRE in mg/dL.
Time frame: 3 months
Change from baseline in the level of CRE at 6-months
Blood samples will be collected to examine changes in CRE in mg/dL.
Time frame: 6 months
Change from baseline in the level of BUN (Blood Urea Nitrogen) at 3-months
Blood samples will be collected to examine changes in BUN in mg/dL.
Time frame: 3 months
Change from baseline in the level of BUN at 6-months
Blood samples will be collected to examine changes in BUN in mg/dL.
Time frame: 6 months
Change from baseline in the level of K+ (Potassium) at 3-months
Blood samples will be collected to examine changes from baseline in K+ in mg/dL.
Time frame: 3 months
Change from baseline in the level of K+ at 6-months
Blood samples will be collected to examine changes from baseline in K+ in mg/dL.
Time frame: 6 months
Change from baseline in the level of Urine protein/albumin at 3-months
Urine samples will be collected to examine changes in Urine protein/albumin in mg/dL.
Time frame: 3 months
Change from baseline in the level of Urine protein/albumin at 6-months
Urine samples will be collected to examine changes in Urine protein/albumin in mg/dL.
Time frame: 6 months
Change from baseline in the level of Urine microalbuminuria/creatinine at 3-months
Urine samples will be collected to examine changes from baseline in Urine protein/albumin in mg/dL.
Time frame: 3 months
Change from baseline in the level of Urine microalbuminuria/creatinine at 6-months
Urine samples will be collected to examine changes from baseline in Urine protein/albumin in mg/dL.
Time frame: 6 months
Change from baseline in the level of Urine acid at 3-months
Urine samples will be collected to examine changes in Urine protein/albumin in mg/dL.
Time frame: 3 months
Change from baseline in the level of Urine acid at 6-months
Urine samples will be collected to examine changes in Urine protein/albumin in mg/dL.
Time frame: 6 months
Change from baseline in the level of CG (The Cockcroft and Gault formula) at 3-months
CG will be calculated with creatinine, age, weight, gender. The equation of CG = (((140 - age in years) x (weight in kg)) x 1.23) / (serum creatinine in micromol/l).
Time frame: 3 months
Change from baseline in the level of CG at 6-months
CG will be calculated with creatinine, age, weight, gender. The equation of CG = (((140 - age in years) x (weight in kg)) x 1.23) / (serum creatinine in micromol/l).
Time frame: 6 months
Change from baseline in the level of eGFR (Estimated Glomerular Filtration Rate) at 3-months
eGFR will be estimated according to the CKD-EPI Creatinine Equation (2021) which is calculated with serum creatinine, Cystatin C, age, gender.
Time frame: 3 months
Change from baseline in the level of eGFR (Estimated Glomerular Filtration Rate) at 6-months
eGFR will be estimated according to the CKD-EPI Creatinine Equation (2021) which is calculated with serum creatinine, Cystatin C, age, gender.
Time frame: 6 months
Change from baseline in levels of blood lipid-related Index at 3 months
Blood samples will be collected to examine variation in TG (Triglyceride), TC (Total Cholesterol), VLDL (Very-Low-Density Lipoprotein), LDL (Low-density lipoprotein), HDL (High-density lipoprotein).
Time frame: 3 months
Change from baseline in levels of blood lipid-related Index at 6 months
Blood samples will be collected to examine variation in TG (Triglyceride), TC (Total Cholesterol), VLDL (Very-Low-Density Lipoprotein), LDL (Low-density lipoprotein), HDL (High-density lipoprotein).
Time frame: 6 months
Change from baseline in levels of cytokines Index at 3 months
Blood samples will be collected to examine variation in hs-CRP (high-sensitivity C-reactive protein), IL-6 (Interleukin-6), IL-18 (Interleukin-18), IL -1-α (Interleukin-1-α), IL-1β (Interleukin-1 β), TNF-α (Tumor necrosis factor-α), NGAL (Neutrophil Gelatinase-Associated Lipocalin), sTNFR1 (Soluble tumour necrosis factor receptor-1), PGRN (Progranulin). All the indexes will be recorded in in pg/mL.
Time frame: 3 months
Change from baseline in levels of cytokines Index at 6 months
Blood samples will be collected to examine variation in hs-CRP, IL-6, IL-18, IL-1-α, IL-1β, TNF-α, NGAL, sTNFR1, PGRN. All the indexes will be recorded in in pg/mL.
Time frame: 6 months
Change from baseline in levels of TIBC (Total Iron-Binding Capacity) at 3-months
TIBC will be calculated by summing the values of serum iron and UIBC(unsaturated iron-binding capacity) which is examed from blood samples.
Time frame: 3 months
Change from baseline in levels of TIBC at 6-months
TIBC will be calculated by summing the values of serum iron and UIBC which is examed from blood samples.
Time frame: 6 months
Change from baseline in the level of SCFA (Short Chain Fatty Acids) at 6 months
Stool samples will be collected to examine variation in SCFA (Short Chain Fatty Acids).
Time frame: 6 months
Change from baseline in the level of TMAO (Trimethylamine N-oxide) at 3-months
Blood samples will be collected to examine variation in TMAO in μmol/L.
Time frame: 3 months
Change from baseline in the level of TMAO at 6-months
Blood samples will be collected to examine variation in TMAO in μmol/L.
Time frame: 6 months
Change from baseline in self-record of the International physical activity questionary (IPAQ) in physical assessment at 6 months
The questionnaire will be recorded the laborious activity by the subject himself/herself before and after the treatment.
Time frame: 6 months
Change from baseline in gut microbiota at 6 months
The analysis of Gut microbiota will utilize DNA sequencing to investigate the intestinal microbiota through stool samples.
Time frame: 6 months
This study is completed, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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GenMont Biotech Incorporation