CompletedNot Applicable

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

Taiwan50 participantsStarted 2023-04-24

Plain-language 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.

Who can participate

Age range

25 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from baseline in Cys-C (Cystatin C) level at 3 months

Timeframe: 3 months

Change from baseline in Cys-C (Cystatin C) level at 6 months

Timeframe: 6 months

Trial details

NCT IDNCT05674981

SponsorGenMont Biotech Incorporation

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-04-24

View on ClinicalTrials.gov More Diabetic Kidney Disease trials