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

NCT05674981 | Completed

• 1 other identifier: DKD2022
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Kidney Disease

Keywords

Diabetic kidney disease; gut microbiota; Probiotic; Lactobacillus reuteri; Lactobacillus rhamnosus

Outcome Measures

Primary Outcomes (2)

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

  Blood samples will be collected to examine the variation of Cys-C (Cystatin C) from baseline at 3 months.

  3 months

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

  Blood samples will be collected to examine the variation of Cys-C from baseline at 6 months.

  6 months

Secondary Outcomes (47)

• Change from baseline in BMI (Body Mass Index) at 3 months

  3 months

• Change from baseline in BMI (Body Mass Index) at 6 months

  6 months

• Change from baseline in Waist and hip circumference at 3 months

  3 months

• Change from baseline in Waist and hip circumference at 6 months

  6 months

• Change from baseline in blood pressure at 3 months

  3 months

Study Arms (2)

Probiotic group

EXPERIMENTAL

Subjects received two probiotic sachets per day

Dietary Supplement: Probiotic group

Placebo group

PLACEBO COMPARATOR

Subjects received two placebo sachets per day

Other: Placebo group

Interventions

Probiotic group DIETARY_SUPPLEMENT

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

Also known as: Test group

Probiotic group

Placebo group OTHER

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

Also known as: Control group

Placebo group

Eligibility Criteria

• Age: 25 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• GenMont Biotech Incorporation: lead
• Chung Shan Medical University: collaborator

Study Sites (1)

Chung Shan Medical University Hospital

Taichung, Taiwan, 402, Taiwan

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Yi-Sun Yang, PhD

  Chung Shan Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel Assignment, Randomized Controlled Trial

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 9, 2023
• Study Start: April 24, 2023
• Primary Completion: April 24, 2025
• Study Completion: May 8, 2025
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

TW (1)