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Clinical study of fecal bacteria transplantation in the treatment of IgA nephropathy

Clinical study of fecal bacteria transplantation in the treatment of IgA nephropathy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100053206
Enrollment
Unknown
Registered
2021-11-14
Start date
2022-01-01
Completion date
Unknown
Last updated
2022-09-20

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

Conditions

IgA nephropathy

Interventions

Experimental group:Fecal transplant

Sponsors

Shanxi Provincial People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1. Subjects: patients with IgA nephropathy diagnosed by renal biopsy; 2. After 3-6 months of ACEI/ARB treatment, urinary protein is still >0.5g/d; 3. eGFR: 30-120ml/min/1.73m^2; 4. Can not tolerate the side effects of glucocorticoids and immunosuppressants; 5. The urine pregnancy test is negative and there is no pregnancy plan in the next 18 months, and effective contraceptive measures are guaranteed; 6. Aged 18-70 years; 7. Inpatients; 8. Sign the informed consent for clinical research and the informed consent of patients treated with microbiota transplantation (FMT).

Exclusion criteria

Exclusion criteria: 1. Secondary IgA nephropathy: such as SLE, liver cirrhosis, IgA vasculitis; 2. Have taken antibiotics in the past 14 days; 3. Malignant hypertension or other uncontrolled severe hypertension (systolic blood pressure>160mmHg or diastolic blood pressure>110mmHg); 4. Active systemic infection or serious infection within 1 month before enrollment, including HIV, HBV, HCV; 5. White blood cell count <3.0x10^9/L, or anemia (hemoglobin <80g/L); platelet count <80x10^9/L, or other blood system diseases; 6. There are malignant tumors and other diseases, and the expected survival time is less than 3 months; 7. Severe cardiovascular and cerebrovascular diseases and intestinal dysfunction; 8. There are other immune system diseases; 9. The presence of IBD, CDI, or gastrointestinal tumors; 10. Active gastrointestinal bleeding or acute and chronic gastrointestinal inflammation; 11. Are or have received FMT; 12. Mental illness and cognitive impairment; 13. History of alcohol or drug abuse.

Design outcomes

Primary

MeasureTime frame
24-h urinary protein quantification;

Secondary

MeasureTime frame
Serum creatinine;Blood urea nitrogen;Urine red blood cells;Urine protein;Serum cystatin C;ß2-microglobulin;

Countries

China

Contacts

Public ContactLi Yafeng

Shanxi Provincial People's Hospital

dr.yafengli@gmail.com+86 13935151151

Outcome results

None listed

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