clinical study on the effect of intestinal probiotics on the progression of diabetic nephropathy

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

ChiCTR

Registry ID

ChiCTR2000035862

Enrollment

Unknown

Registered

2020-08-18

Start date

2020-10-01

Completion date

Unknown

Last updated

2020-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

diabetic

Interventions

intervention group:probiotics

placebo group:placebo

Eligibility

Sex/Gender

All

Age

20 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. Meet the diagnostic standard of diabetes mellitus of WTO in 1999, excluding Type 1 diabetes and other special types of diabetes,Clinical diagnosis of diabetic nephropathy stage IV patients (urinary albumin creatinine ratio > 30 ug / Mg, American Diabetes Association recommended diagnostic criteria); 2. Serum albumin > 35g / L, EGFR 20 ~ 45ml / min*1.73m2; 3. In order to avoid the influence of diet, blood glucose, blood pressure and blood lipid, the following requirements are required: (1) traditional diabetes diet with Chinese characteristics; (2) glycosylated hemoglobin (HbA1c) of 6-8%; (3) blood pressure < 140 / 90mmHg; (4) low density lipoprotein cholesterol < 3.38 mmol/L, blood triglyceride < 2.26 mmol/L.

Exclusion criteria

Exclusion criteria: 1) Suffering from tumor, hypertension, coronary heart disease, liver cirrhosis, fatty liver, asthma; 2) Patients with special diet; 3) Other endocrine diseases such as thyroid gland; 4) Antibiotics and probiotics were taken in the past month; 5) Diarrhea or other gastrointestinal diseases in the past 4 weeks; 6) Previous gastrointestinal surgery history; 7) Other primary or secondary renal damage factors were excluded.

Design outcomes

Primary

Measure	Time frame
Serum creatinine;eGFR;24h urine protein;Proteolytic microbiome concentration;glycolytic microflora concentration;	—

Secondary

Measure	Time frame
Serum triglycerides;LDL/HDL;indoxyl sulfate;P-cresol sulfate;IL-6;CRP;lipopolysaccharide, LPS;LPS-binding protein (LBP);soluble CD14 (sCD14);hemoglobin;Fat free weight;Fat weight;grip;Total moisture;	—

Countries

China

Contacts

Public ContactWeiming Wang

Nephrology department of Ruijin Hospital North affiliated to Shanghai JiaoTong university school of medicine

wweiming01@126.com+86 18121263223

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026