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

NCT ID: NCT05674981

Last Updated: 2025-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-24
• Study Completion Date: 2025-05-08

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.

Conditions

Diabetic Kidney Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

Probiotic group

Subjects received two probiotic sachets per day

Group Type: EXPERIMENTAL

Probiotic group

Intervention Type: DIETARY_SUPPLEMENT

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

Placebo group

Subjects received two placebo sachets per day

Group Type: PLACEBO_COMPARATOR

Placebo group

Intervention Type: OTHER

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

Interventions

Probiotic group

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

Intervention Type: DIETARY_SUPPLEMENT

Placebo group

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

Intervention Type: OTHER

Other Intervention Names

Test group; Control group

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 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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GenMont Biotech Incorporation

INDUSTRY

Sponsor Role: lead

Chung Shan Medical University

OTHER

Sponsor Role: collaborator

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yi-Sun Yang, PhD

Role: PRINCIPAL_INVESTIGATOR

Chung Shan Medical University

Locations

Chung Shan Medical University Hospital

Taichung, Taiwan, Taiwan

Countries

Taiwan

Other Identifiers

DKD2022

Identifier Type: -

Identifier Source: org_study_id