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

Launched by GENMONT BIOTECH INCORPORATION · Dec 29, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Diabetic Kidney Disease Gut Microbiota Probiotic Lactobacillus Reuteri Lactobacillus Rhamnosus

ClinConnect Summary

This clinical trial is studying the effects of probiotics on patients with diabetic kidney disease (DKD). Specifically, researchers want to see if taking a mixture of two types of probiotics—lactobacillus reuteri and lactobacillus rhamnosus—for six months can help improve blood sugar levels and kidney function in individuals with DKD. The idea is that these probiotics might help create a healthier balance of bacteria in the gut, which could lead to better overall health and slow the progression of kidney disease.

To participate in this trial, individuals need to be between 25 and 80 years old, have type 2 diabetes with stable medication for at least three months, and have certain levels of kidney function and blood sugar. However, those with type 1 diabetes, severe kidney issues, certain other health conditions, or who have taken certain medications recently may not be eligible. Participants can expect to take the probiotic powder daily and will be monitored for changes in their health over the study period. This trial is currently recruiting, so if you or someone you know is interested, it might be a great opportunity to contribute to important research in diabetic kidney disease.

Gender

ALL

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

About Genmont Biotech Incorporation

Genmont Biotech Incorporation is a pioneering biotechnology company dedicated to advancing innovative therapeutic solutions through cutting-edge research and development. With a focus on harnessing the potential of biopharmaceuticals, Genmont is committed to addressing unmet medical needs across various therapeutic areas, including oncology, immunology, and rare diseases. The company prides itself on its robust pipeline of clinical trials aimed at delivering safe and effective treatments, leveraging state-of-the-art technologies and a team of experienced professionals. Through strategic collaborations and a commitment to scientific excellence, Genmont Biotech strives to enhance patient outcomes and contribute to the future of healthcare.

Locations

Taichung City, , Taiwan

Patients applied

0 patients applied

Trial Officials

Yi-Sun Yang, PhD

Principal Investigator

Chung Shan Medical University

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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