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A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of Fecal Microbiota Capsule Transplantation Combined with Henagliflozin in Patients with Type 2 Diabetic Kidney Disease

A Prospective, Randomized, Double-Blind, Placebo-Controlled Clinical Study Evaluating the Efficacy and Safety of Fecal Microbiota Capsule Transplantation Combined with Henagliflozin in Patients with Type 2 Diabetic Kidney Disease

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500107368
Enrollment
Unknown
Registered
2025-08-11
Start date
2025-08-15
Completion date
Unknown
Last updated
2025-08-18

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

Conditions

Type 2 Diabetic Kidney Disease

Interventions

Cohort of Ertugliflozin and Fecal Microbiota Capsules:Cohort of Ertugliflozin and Fecal Microbiota Capsules
Entrectinib placebo-controlled group:Ertugliflozin and placebo

Sponsors

Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: (1) Age between 18 and 65 years (including 18 and 65 years); (2) Patients with newly diagnosed diabetes or those who have been on a stable dosage treatment for at least 4 weeks, with poor glucose control (7.0% <=HbA1c <=11.0%) for type 2 diabetes (WHO criteria, 1999); (3) Meet the diagnostic criteria for Diabetic Kidney Disease, with 45 < GFR < 60 ml/min/1.73m; (4) Willing to sign an informed consent form.

Exclusion criteria

Exclusion criteria: (1) Type 1 diabetes, special types of diabetes (such as diabetes caused by pancreatic damage, Cushing's syndrome, or diabetes induced by acromegaly, etc.); (2) Patients with diabetic ketoacidosis, hyperglycemic hyperosmolar state, lactic acidosis, dehydration, eating disorders, or severe dysfunction of vital organs (heart, liver, lungs, kidneys, etc.) (recent (within the last 12 months) myocardial infarction and cerebral infarction, decreased cardiac output index, unstable angina, arrhythmias, hypotension, circulatory failure, etc.); (3) Those with ALT and AST levels more than three times the normal upper limit, glomerular filtration rate =180 mmHg and/or DBP >= 110 mmHg; (4) Currently suffering from severe gastrointestinal diseases affecting drug absorption, distribution, metabolism, and excretion, or having a history of gastrointestinal surgery affecting drug absorption, such as gastrointestinal ostomy or bowel resection; (5) Patients with a history of pancreatitis, active gallbladder disease, frequent gout, kidney failure, pregnancy and lactation, current infections, or those with extremely poor physical condition who cannot cooperate; (6) Endocrine disorders, such as hyperthyroidism, hypothyroidism, and diseases like Cushing's syndrome that affect glucose and lipid metabolism.

Design outcomes

Primary

MeasureTime frame
Random urine albumin/creatinine ratio, ACR;

Countries

China

Contacts

Public ContactYong Xu

Affiliated Hospital of Southwest Medical University

xywyll@aliyun.com+86 139 8025 5895

Outcome results

None listed

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