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Safety and efficacy of fecal microbiota transplantation in the treatment of diabetic nephropathy: a randomized controlled clinical trial

Safety and efficacy of fecal microbiota transplantation in the treatment of diabetic nephropathy: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400087787
Enrollment
Unknown
Registered
2024-08-05
Start date
2024-08-10
Completion date
Unknown
Last updated
2025-04-21

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

Conditions

Diabetic nephropathy

Interventions

Experimental group:Basic therapy combined with fecal bacteria transplantation (capsule)
Control group:Basic treatment combined with placebo capsules

Sponsors

The First Affiliated Hospital of the Air Force Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: a) Adult, age: 18-80 years old; b) Pathological diagnosis of diabetic nephropathy; c)eGFR>=30mL/min/ 1.73m^2; d) Have a fixed medication plan within the last 3 months; e) Urinary albumin/creatinine ratio 300 to 8000mg/g or 24-hour urinary protein 300 to 8000mg; f) Agree to participate in the project and sign the informed consent.

Exclusion criteria

Exclusion criteria: a) diabetic ketoacidosis, hyperosmolar non-ketotic coma, or acute complications of diabetes; b) The expected survival time of severe cardiovascular and cerebrovascular diseases, pulmonary insufficiency, malignant tumors and other diseases is less than 3 months; c) Aii autoimmune disease; d) gastrointestinal active bleeding; e) Acute gastroenteritis; f) have previously received or are receiving FMT treatment; g) HIV infection; h) Regular administration of probiotics within 3 months before enrollment i) mental illness or intellectual disability; j) Women who have a pregnancy plan or are breastfeeding within 18 months; k) Alcohol/drug abuse history; l) Other conditions deemed unsuitable for inclusion by the researchers.

Design outcomes

Primary

MeasureTime frame
Urinary albumin/creatinine ratio at 6 months compared with baseline;

Secondary

MeasureTime frame
Creatinine doubling, eGFR reduction >= 40%, or ESRD;Changes of fasting blood glucose at 6 and 12 months after enrollment;Changes of glycosylated hemoglobin at 6 and 12 months after enrollment;Changes of blood lipid concentration at 6 and 12 months after enrollment;Intestinal flora changed after 6 and 12 months;Adverse reactions during treatment and follow-up.;

Countries

China

Contacts

Public ContactShiren Sun

The First Affiliated Hospital of the Air Force Medical University

sunshiren@medmail.com.cn+86 136 7922 0706

Outcome results

None listed

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