A Clinical Research on the Use of Fecal Bacteria Transplantation for Treatment of IgA Nephropathy
IgA Nephropathy
About this trial
This is an interventional treatment trial for IgA Nephropathy focused on measuring IgAN, FMT
Eligibility Criteria
Inclusion Criteria:
- (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 Criteria:
- (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
Sites / Locations
- Shanxi Provincial People's HospitaRecruiting
Arms of the Study
Arm 1
Experimental
experimental group
This trial is a prospective study without a control group. It is planned to recruit 15 patients with IgA nephropathy. The experimental group received fecal bacteria transplantation through FMT capsule. The researchers will judge the effectiveness and safety of fecal bacteria transplantation in the treatment of IgA nephropathy by observing the changes of monitoring indicators before and after fecal bacteria transplantation and during follow-up. Donor screening and FMT capsule preparation were completed by Dongyuan Yikang company (www.dongyuanyikang. com).The patients participating in the trial took 16 Enterobacteriaceae capsules on day 1, day 8 and day 15 respectively as a course of treatment. The researchers will collect stool samples from patients one day before taking the medicine, one week after the last taking the medicine and one month after the last taking the medicine, and analyze the intestinal flora by sequencing