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NCT05674981
To Evaluate the Beneficial Effect of Probiotics on DKD Patients and the Role of Gut Microbiota Modulation
Conditions: Diabetic Kidney Disease
Sex: All
Ages: 25 Years – 80 Years
Phase: NA
Enrollment: 50
Sponsor: GenMont Biotech Incorporation
Location: Taiwan
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.
Eligibility Criteria
Inclusion Criteria:Age between 25 and 80 years oldSuffering from type 2 diabetes and stable medication for 3 monthsDetection of HbA1c before meals between 7% and 10%Stage 1-3a diabetic nephropathies (eGFR > 45 mL/min)Microalbuminuria estimated between 30 to 300 mg/dayExclusion Criteria:Patients with Type I Diabetes MelliusPatients 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 monthFasting blood glucose >13.3 mmol/LGPT>100U/L (2.5 times than usual situation)Vulnerable population (Including breeding or pregnant women, prisoner, aboriginal, disabled population)Smoker or AlcoholicTaking Antibiotics in past 1 monthStably 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
Source: ClinicalTrials.gov (NCT05674981). StuddyBuddy aggregates publicly available trial information.