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Application of faecal microbiota transplantation in diabetic nephropathy

Application of faecal microbiota transplantation in diabetic nephropathy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100046664
Enrollment
Unknown
Registered
2021-05-26
Start date
2021-08-01
Completion date
Unknown
Last updated
2022-01-04

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

Conditions

Diabetic Nephropathy

Interventions

Control group:Live Combined Bifidobacterium and Lactobacillus Tablets

Sponsors

Affiliated Hospital of Southwest Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Type 1 or type 2 diabetic nephropathy; 2. Aged 18 to 70 years; 3. HbA1c<11%; 4. Diabetic gastrointestinal autonomic neuropathy (chronic diarrhea, constipation, or alternate diarrhea with constipation), recurrent Clostridium difficile infection, antibiotic-related diarrhea, refractory bowel disease (including intestinal infection, refractory Crohn's disease, refractory ulcerative colitis, intestinal fistula combined with infection, refractory constipation, etc.); 5. Responded poorly to conventional treatments for at least 3 months.

Exclusion criteria

Exclusion criteria: 1. Had a continuous antibiotic microecological preparations and other drugs that could influence intestinal flora for >3 days within 3 months prior to enrolment; 2. Had other causes of chronic kidney disease, such as various primary and secondary glomerulonephritis, renal tubular injury and renal vascular lesions, nephrotic syndrome, connective tissue disease, drug etc; 3. Serious heart disease, lung disease; 4. Difficult sedation of nerve, mental disorders, severe mental retardation, epileptic status; 5. Acute perforation of digestive tract was suspected; Shock coma, extreme weakness and inability to tolerate; 6. Acute stage of upper digestive tract corrosive inflammation, massive ascites, severe abdominal distension, severe spinal deformity, aortic aneurysm, acute peritonitis or extensive adhesion in the abdominal cavity; 7. Patients who cannot cooperate and are not suitable for general anesthesia, severe hemorrhagic diseases, abnormal coagulation function, poor immune status, and long-term use of immunosuppressant 8. Patients with severe intestinal ulcer, gastrointestinal malformation, postoperative adhesion, and organic obstruction; 9. Had a physical disability or self-care disability or were unable to recall clearly and answer questions due to any other reasons; lacked the time to take part in this project.

Design outcomes

Primary

MeasureTime frame
24-hour urinary protein quantity;Urine trace albumin;Glomerular filtration rate;

Secondary

MeasureTime frame
Venous blood sugar;Blood urea nitrogen;Serum creatinine;Urine trace albumin/creatinine;

Countries

China

Contacts

Public ContactXu Yong

Affiliated Hospital of Southwest Medical University

xywyll@aliyun.com+86 13980255895

Outcome results

None listed

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