Status:
COMPLETED
A Clinical Research on the Use of Fecal Bacteria Transplantation for Treatment of IgA Nephropathy
Lead Sponsor:
Shanxi Provincial People's Hospital
Conditions:
IgA Nephropathy
Eligibility:
All Genders
18-70 years
Phase:
NA
Brief Summary
The role and related mechanisms of gut microecology in the development and progression of IgA nephropathy were investigated by treating IgA nephropathy subjects with oral probiotic capsules (FMT) comb...
Detailed Description
IgA Nephropathy (IgAN) is a serious threat to human health. The exact pathogenesis of IgAN has not been elucidated yet. Currently, there is no specific and effective treatment except supportive therap...
Eligibility Criteria
Inclusion
- (1) Subjects: IgA nephropathy patients diagnosed by renal biopsy (2) After 3 \~ 6 months of ACEI / ARB treatment, urinary protein was still \> 0.5g/d (3) eGFR30 120ml/min/1.73 ㎡ (4) Unable to tolerate the side effects of glucocorticoids and immunosuppressants (5) If the urine pregnancy test is negative and there is no pregnancy plan in the next 18 months, effective contraceptive measures can be taken (6) Age: 18-70 years old (7) Inpatient (8) Sign the informed consent form for clinical research and the informed consent form for patients treated with flora transplantation (FMT)
Exclusion
- (1) Secondary IgA nephropathy: such as SLE, liver cirrhosis, IgA vasculitis (2) Antibiotics in recent 14 days (3) Malignant hypertension or other uncontrollable 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 and HCV (5) Leukocyte count \< 3.0x109 / L, or anemia (hemoglobin \< 80g / L); Platelet count \< 80x10 9 / L,Or other blood system diseases (6) There were malignant tumors and other diseases, and the expected survival time was \< 3 months (7) Severe cardiovascular and cerebrovascular diseases and intestinal dysfunction (8) There are other immune system diseases (9) Presence of IBD, CDI, or gastrointestinal tumors (10) There is active gastrointestinal bleeding or acute and chronic gastrointestinal inflammation (11) Being or having received FMT (12) Psychosis and cognitive impairment (13) History of alcohol or drug abuse
Key Trial Info
Start Date :
January 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2023
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT05182775
Start Date
January 1 2022
End Date
December 31 2023
Last Update
March 11 2025
Active Locations (1)
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1
Shanxi Provincial People's Hospita
Taiyuan, Shanxi, China, 030012