Evaluating probiotics for improving diabetic kidney disease
To Evaluate the Clinical Efficacy of Probiotic in Patients with DKD
NA · GenMont Biotech Incorporation · NCT05674981
This study is testing whether taking specific probiotics can help people with diabetic kidney disease improve their blood sugar levels and kidney function.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 50 (estimated) |
| Ages | 25 Years to 80 Years |
| Sex | All |
| Sponsor | GenMont Biotech Incorporation (industry) |
| Locations | 1 site (Taichung City) |
| Trial ID | NCT05674981 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of probiotics, specifically Lactobacillus reuteri and Lactobacillus rhamnosus, in patients with diabetic kidney disease. Participants will consume probiotic sachets for six months, and the study will monitor changes in blood sugar levels and kidney function indicators. The hypothesis is that probiotics can enhance gut microbiota, reduce oxidative stress, and improve metabolic balance, potentially slowing the progression of diabetic kidney disease. Previous research has indicated that probiotics may positively influence diabetes-related complications, making this investigation particularly relevant.
Who should consider this trial
Good fit: Ideal candidates are adults aged 25 to 80 with type 2 diabetes and stage 1-3a diabetic nephropathy.
Not a fit: Patients with type 1 diabetes, severe complications, or certain comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel dietary intervention to improve kidney function and metabolic control in diabetic patients.
How similar studies have performed: Previous studies have shown promising results regarding the use of probiotics in managing diabetic kidney disease, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Taichung City
- Chung Shan Medical University Hospital — Taichung City, Taiwan (RECRUITING)
Study contacts
- Principal investigator: Yi-Sun Yang, PhD — Chung Shan Medical University
- Study coordinator: Fang-Kuei Lin, Master
- Email: meitung@genmont.com.tw
- Phone: +886-6-505-2151
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Diabetic Kidney Disease, Diabetic kidney disease, gut microbiota, Probiotic, Lactobacillus reuteri, Lactobacillus rhamnosus