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Diabetic Kidney DiseaseNCT05674981

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

A study testing Probiotic group in people with Diabetic Kidney Disease, run by GenMont Biotech Incorporation at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 25 to 80 years
Conditions the study is for
Diabetic Kidney Disease
What is being tested?
Probiotic group
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
50 participants
Where
1 siteTaiwan
Study dates
24 Apr 2023to 8 May 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 25 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 11Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Chung Shan Medical University Hospital

    Taichung, Taiwan, 402

Other trials in Taiwan

About this study

Official title: To Evaluate the Clinical Efficacy of Probiotic in Patients With DKD

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.

Read the 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.

Being tested
Probiotic group, Placebo group
Keywords
Diabetic kidney disease, gut microbiota, Probiotic, Lactobacillus reuteri, Lactobacillus rhamnosus
Medical subject headings
Diabetic Nephropathies

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Probiotic groupDietary supplement

    Also called Test group

    Two-strain probiotic supplement includes Lactobacillus reuteri ADR-1 (alive) and Lactobacillus rhamnosus GM-020 ( alive).

  • Placebo groupOther

    Also called Control group

    Same additives to Probiotic group but replace probiotics with corn starch and Maltodextrin.

Study groups in NCT05674981
Study groupRoleWhat they receive
Probiotic groupExperimentalSubjects received two probiotic sachets per day
Receives: Dietary Supplement: Probiotic group
Placebo groupPlacebo comparatorSubjects received two placebo sachets per day
Receives: Other: Placebo group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 3 months

  2. 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.

    Measured: 6 months

Secondary outcomes (47)

  1. Change from baseline in BMI (Body Mass Index) at 3 months

    BMI will be calculated with weight and height combined in kg/m^2.

    Measured: 3 months

  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.

    Measured: 6 months

  3. Change from baseline in Waist and hip circumference at 3 months

    Waist and hip circumference will take down in centimeters.

    Measured: 3 months

  4. Change from baseline in Waist and hip circumference at 6 months

    Waist and hip circumference will take down in centimeters.

    Measured: 6 months

  5. 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.

    Measured: 3 months

  6. 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.

    Measured: 6 months

  7. 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.

    Measured: 3 months

  8. Change from baseline in levels of FPG at 6-months

    Fasting blood samples will be collected to examine variation in FPG in uIU/mL.

    Measured: 6 months

  9. 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.

    Measured: 3 months

  10. 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.

    Measured: 6 months

  11. 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 %.

    Measured: 3 months

  12. Change from baseline in levels of HbA1c at 6-months

    Fasting blood samples will be collected to investigate the levels of HbA1c in %.

    Measured: 6 months

  13. 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)

    Measured: 3 months

  14. Change from baseline in levels of HOMA-IR at 6-months

    The equation of HOMA-IR=(insulin (mIU/L) and glucose (mg/dl))/405)

    Measured: 6 months

  15. 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

    Measured: 3 months

  16. 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

    Measured: 6 months

  17. 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))]

    Measured: 3 months

  18. 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))]

    Measured: 6 months

  19. 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.

    Measured: 3 months

  20. 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.

    Measured: 6 months

  21. 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.

    Measured: 3 months

  22. Change from baseline in the level of CRE at 6-months

    Blood samples will be collected to examine changes in CRE in mg/dL.

    Measured: 6 months

  23. 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.

    Measured: 3 months

  24. Change from baseline in the level of BUN at 6-months

    Blood samples will be collected to examine changes in BUN in mg/dL.

    Measured: 6 months

  25. 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.

    Measured: 3 months

  26. 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.

    Measured: 6 months

  27. 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.

    Measured: 3 months

  28. 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.

    Measured: 6 months

  29. 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.

    Measured: 3 months

  30. 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.

    Measured: 6 months

  31. 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.

    Measured: 3 months

  32. 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.

    Measured: 6 months

  33. 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).

    Measured: 3 months

  34. 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).

    Measured: 6 months

  35. 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.

    Measured: 3 months

  36. 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.

    Measured: 6 months

  37. 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).

    Measured: 3 months

  38. 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).

    Measured: 6 months

  39. 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.

    Measured: 3 months

  40. 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.

    Measured: 6 months

  41. 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.

    Measured: 3 months

  42. 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.

    Measured: 6 months

  43. 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).

    Measured: 6 months

  44. 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.

    Measured: 3 months

  45. Change from baseline in the level of TMAO at 6-months

    Blood samples will be collected to examine variation in TMAO in μmol/L.

    Measured: 6 months

  46. 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.

    Measured: 6 months

  47. 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.

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jan 2023
  2. Study start24 Apr 2023
  3. Primary completion24 Apr 2025
  4. Study completion8 May 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Parallel Assignment, Randomized Controlled Trial
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05674981
Sponsor's protocol ID
DKD2022
Status last verified
Dec 2025
First submitted
19 Dec 2022
Last updated
8 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Probiotic group in people with Diabetic Kidney Disease, run by GenMont Biotech Incorporation at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Cys-C (Cystatin C) level at 3 months (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05674981.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Dec 2025.

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