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To Evaluate the Beneficial Effect of Probiotics on DKD Patients and the Role of Gut Microbiota Modulation

Primary Purpose

Diabetic Kidney Disease

Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Probiotic group
Placebo group
Sponsored by
GenMont Biotech Incorporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetic Kidney Disease focused on measuring Diabetic kidney disease, gut microbiota, Probiotic, Lactobacillus reuteri, Lactobacillus rhamnosus

Eligibility Criteria

25 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: Patients with Type I Diabetes Mellius 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

Sites / Locations

  • Chung Shan Medical University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Probiotic group

Placebo group

Arm Description

Subjects received two probiotic sachets per day

Subjects received two placebo sachets per day

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Change from baseline in BMI (Body Mass Index) at 3 months
BMI will be calculated with weight and height combined in kg/m^2.
Change from baseline in BMI (Body Mass Index) at 6 months
BMI will be calculated with weight and height combined in kg/m^2.
Change from baseline in Waist and hip circumference at 3 months
Waist and hip circumference will take down in centimeters.
Change from baseline in Waist and hip circumference at 6 months
Waist and hip circumference will take down in centimeters.
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.
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.
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.
Change from baseline in levels of FPG at 6-months
Fasting blood samples will be collected to examine variation in FPG in uIU/mL.
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.
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.
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 %.
Change from baseline in levels of HbA1c at 6-months
Fasting blood samples will be collected to investigate the levels of HbA1c in %.
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)
Change from baseline in levels of HOMA-IR at 6-months
The equation of HOMA-IR=(insulin (mIU/L) and glucose (mg/dl))/405)
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
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
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))]
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))]
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.
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.
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.
Change from baseline in the level of CRE at 6-months
Blood samples will be collected to examine changes in CRE in mg/dL.
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.
Change from baseline in the level of BUN at 6-months
Blood samples will be collected to examine changes in BUN in mg/dL.
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.
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.
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.
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.
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.
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.
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.
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.
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).
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).
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.
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.
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).
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).
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.
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.
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.
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.
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).
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.
Change from baseline in the level of TMAO at 6-months
Blood samples will be collected to examine variation in TMAO in μmol/L.
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.
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.

Full Information

First Posted
December 19, 2022
Last Updated
May 11, 2023
Sponsor
GenMont Biotech Incorporation
Collaborators
Chung Shan Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05674981
Brief Title
To Evaluate the Beneficial Effect of Probiotics on DKD Patients and the Role of Gut Microbiota Modulation
Official Title
To Evaluate the Clinical Efficacy of Probiotic in Patients With DKD
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 24, 2023 (Actual)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
January 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GenMont Biotech Incorporation
Collaborators
Chung Shan Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Kidney Disease
Keywords
Diabetic kidney disease, gut microbiota, Probiotic, Lactobacillus reuteri, Lactobacillus rhamnosus

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment, Randomized Controlled Trial
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Probiotic group
Arm Type
Experimental
Arm Description
Subjects received two probiotic sachets per day
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Subjects received two placebo sachets per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Probiotic group
Other Intervention Name(s)
Test group
Intervention Description
Two-strain probiotic supplement includes Lactobacillus reuteri ADR-1 (alive) and Lactobacillus rhamnosus GM-020 ( alive).
Intervention Type
Other
Intervention Name(s)
Placebo group
Other Intervention Name(s)
Control group
Intervention Description
Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.
Primary Outcome Measure Information:
Title
Change from baseline in Cys-C (Cystatin C) level at 3 months
Description
Blood samples will be collected to examine the variation of Cys-C (Cystatin C) from baseline at 3 months.
Time Frame
3 months
Title
Change from baseline in Cys-C (Cystatin C) level at 6 months
Description
Blood samples will be collected to examine the variation of Cys-C from baseline at 6 months.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from baseline in BMI (Body Mass Index) at 3 months
Description
BMI will be calculated with weight and height combined in kg/m^2.
Time Frame
3 months
Title
Change from baseline in BMI (Body Mass Index) at 6 months
Description
BMI will be calculated with weight and height combined in kg/m^2.
Time Frame
6 months
Title
Change from baseline in Waist and hip circumference at 3 months
Description
Waist and hip circumference will take down in centimeters.
Time Frame
3 months
Title
Change from baseline in Waist and hip circumference at 6 months
Description
Waist and hip circumference will take down in centimeters.
Time Frame
6 months
Title
Change from baseline in blood pressure at 3 months
Description
The unit of measurement of blood pressure is mmHg. Both systolic and diastolic blood pressure will be measured.
Time Frame
3 months
Title
Change from baseline in blood pressure at 6 months
Description
The unit of measurement of blood pressure is mmHg. Both systolic and diastolic blood pressure will be measured.
Time Frame
6 months
Title
Change from baseline in levels of FPG (Fasting Plasma Glucose) at 3-months
Description
Fasting blood samples will be collected to examine variation in FPG in uIU/mL.
Time Frame
3 months
Title
Change from baseline in levels of FPG at 6-months
Description
Fasting blood samples will be collected to examine variation in FPG in uIU/mL.
Time Frame
6 months
Title
Change from baseline in levels of serum insulin at 3-months
Description
Fasting blood samples will be collected to examine variation in serum insulin in uIU/mL.
Time Frame
3 months
Title
Change from baseline in levels of serum insulin at 6-months
Description
Fasting blood samples will be collected to examine variation in serum insulin in uIU/mL.
Time Frame
6 months
Title
Change from baseline in levels of HbA1c (Hemoglobin A1C) at 3-months
Description
Fasting blood samples will be collected to investigate the levels of HbA1c in %.
Time Frame
3 months
Title
Change from baseline in levels of HbA1c at 6-months
Description
Fasting blood samples will be collected to investigate the levels of HbA1c in %.
Time Frame
6 months
Title
Change from baseline in levels of HOMA-IR (Homeostatic Model Assessment for Insulin Resistance) at 3-months
Description
The equation of HOMA-IR=(insulin (mIU/L) and glucose (mg/dL))/405)
Time Frame
3 months
Title
Change from baseline in levels of HOMA-IR at 6-months
Description
The equation of HOMA-IR=(insulin (mIU/L) and glucose (mg/dl))/405)
Time Frame
6 months
Title
Change from baseline in levels of HOMA-β (Homeostatic Model Assessment for β-cell function) at 3-months
Description
The equation of HOMA-β=20 × fasting insulin (μIU/ml)/fasting glucose (mmol/ml) - 3.5
Time Frame
3 months
Title
Change from baseline in levels of HOMA-β (Homeostatic Model Assessment for β-cell function) at 6-months
Description
The equation of HOMA-β=20 × fasting insulin (μIU/ml)/fasting glucose (mmol/ml) - 3.5
Time Frame
6 months
Title
Change from baseline in levels of QUICKI (Quantitative Insulin Sensitivity Check Index) at 3-months
Description
The equation of QUICKI=1 / [log(Fasting Insulin (µU/ml) + log(Fasting Glucose (mg/dL))]
Time Frame
3 months
Title
Change from baseline in levels of QUICKI (Quantitative Insulin Sensitivity Check Index) at 6-months
Description
The equation of QUICKI=1 / [log(Fasting Insulin (µU/ml) + log(Fasting Glucose (mg/dL))]
Time Frame
6 months
Title
Change from baseline in the level of GA (Glycated albumin) at 3-months
Description
Blood samples will be collected to examine changes in GA in mg/dL.
Time Frame
3 months
Title
Change from baseline in the level of GA (Glycated albumin) at 6-months
Description
Blood samples will be collected to examine changes in GA in mg/dL.
Time Frame
6 months
Title
Change from baseline in the level of CRE (Creatinine) at 3-months
Description
Blood samples will be collected to examine changes in CRE in mg/dL.
Time Frame
3 months
Title
Change from baseline in the level of CRE at 6-months
Description
Blood samples will be collected to examine changes in CRE in mg/dL.
Time Frame
6 months
Title
Change from baseline in the level of BUN (Blood Urea Nitrogen) at 3-months
Description
Blood samples will be collected to examine changes in BUN in mg/dL.
Time Frame
3 months
Title
Change from baseline in the level of BUN at 6-months
Description
Blood samples will be collected to examine changes in BUN in mg/dL.
Time Frame
6 months
Title
Change from baseline in the level of K+ (Potassium) at 3-months
Description
Blood samples will be collected to examine changes from baseline in K+ in mg/dL.
Time Frame
3 months
Title
Change from baseline in the level of K+ at 6-months
Description
Blood samples will be collected to examine changes from baseline in K+ in mg/dL.
Time Frame
6 months
Title
Change from baseline in the level of Urine protein/albumin at 3-months
Description
Urine samples will be collected to examine changes in Urine protein/albumin in mg/dL.
Time Frame
3 months
Title
Change from baseline in the level of Urine protein/albumin at 6-months
Description
Urine samples will be collected to examine changes in Urine protein/albumin in mg/dL.
Time Frame
6 months
Title
Change from baseline in the level of Urine microalbuminuria/creatinine at 3-months
Description
Urine samples will be collected to examine changes from baseline in Urine protein/albumin in mg/dL.
Time Frame
3 months
Title
Change from baseline in the level of Urine microalbuminuria/creatinine at 6-months
Description
Urine samples will be collected to examine changes from baseline in Urine protein/albumin in mg/dL.
Time Frame
6 months
Title
Change from baseline in the level of Urine acid at 3-months
Description
Urine samples will be collected to examine changes in Urine protein/albumin in mg/dL.
Time Frame
3 months
Title
Change from baseline in the level of Urine acid at 6-months
Description
Urine samples will be collected to examine changes in Urine protein/albumin in mg/dL.
Time Frame
6 months
Title
Change from baseline in the level of CG (The Cockcroft and Gault formula) at 3-months
Description
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
Title
Change from baseline in the level of CG at 6-months
Description
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
Title
Change from baseline in the level of eGFR (Estimated Glomerular Filtration Rate) at 3-months
Description
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
Title
Change from baseline in the level of eGFR (Estimated Glomerular Filtration Rate) at 6-months
Description
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
Title
Change from baseline in levels of blood lipid-related Index at 3 months
Description
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
Title
Change from baseline in levels of blood lipid-related Index at 6 months
Description
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
Title
Change from baseline in levels of cytokines Index at 3 months
Description
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
Title
Change from baseline in levels of cytokines Index at 6 months
Description
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
Title
Change from baseline in levels of TIBC (Total Iron-Binding Capacity) at 3-months
Description
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
Title
Change from baseline in levels of TIBC at 6-months
Description
TIBC will be calculated by summing the values of serum iron and UIBC which is examed from blood samples.
Time Frame
6 months
Title
Change from baseline in the level of SCFA (Short Chain Fatty Acids) at 6 months
Description
Stool samples will be collected to examine variation in SCFA (Short Chain Fatty Acids).
Time Frame
6 months
Title
Change from baseline in the level of TMAO (Trimethylamine N-oxide) at 3-months
Description
Blood samples will be collected to examine variation in TMAO in μmol/L.
Time Frame
3 months
Title
Change from baseline in the level of TMAO at 6-months
Description
Blood samples will be collected to examine variation in TMAO in μmol/L.
Time Frame
6 months
Title
Change from baseline in self-record of the International physical activity questionary (IPAQ) in physical assessment at 6 months
Description
The questionnaire will be recorded the laborious activity by the subject himself/herself before and after the treatment.
Time Frame
6 months
Title
Change from baseline in gut microbiota at 6 months
Description
The analysis of Gut microbiota will utilize DNA sequencing to investigate the intestinal microbiota through stool samples.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: Patients with Type I Diabetes Mellius 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fang-Kuei Lin, Master
Phone
+886-6-505-2151
Ext
326
Email
meitung@genmont.com.tw
First Name & Middle Initial & Last Name or Official Title & Degree
Wan-Hua Tsai, PhD
Phone
+886-6-505-2151
Ext
322
Email
twh@genmont.com.tw
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Sun Yang, PhD
Organizational Affiliation
Chung Shan Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chung Shan Medical University Hospital
City
Taichung City
ZIP/Postal Code
402
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yi-Sun Yang, MD-PhD

12. IPD Sharing Statement

Learn more about this trial

To Evaluate the Beneficial Effect of Probiotics on DKD Patients and the Role of Gut Microbiota Modulation

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