CKD
Conditions
Keywords
Fecal Microbiota Transplantation (FMT), Chronic Kidney Disease (CKD)
Brief summary
Wahsed microbiota transplantation (WMT) is a novel and promising therapeutic method for Chronic Kidney Disease (CKD). This clinical trail aims to evaluate the efficacy and safety of WMT in the treatment of CKD.
Detailed description
Although the therapeutic methods progress, numerous patients with Chronic Kidney Disease (CKD) can not avoid the clinical outcome of end-stage renal disease. CKD still needs novel treatment to significantly improve the survival quality of the patients. Gut microbiota has been verified to have relation with immunity. Immunity plays a role in many chronic kidney disease, such as IgA nephropathy, membranous nephropathy and so on. Fecal microbiota transplantation (FMT) is a novel, safe, convenient therapeutic treatment which transplant gut microbiota from donor to patient to rebuild a gut microecology. This study aims to evaluate the efficacy and safety of FMT in CKD patients. Patients in this study will undergo three times WMT. The primary outcome measure was the clinical remission efficacy rate in the CKD patients. The secondary outcome measure was the safety of WMT in CKD.
Interventions
DRUGFecal Microbiota Transplantation
Biologically active human fecal fluid (donor stool) is provided in fluid form.
OTHERStandard of Care for Chronic Kidney Disease
Patients accepted oral drug or dialytic therapy like they used to be to treat CKD.
Sponsors
The Second Hospital of Nanjing Medical University
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
16 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Being diagnosed with chronic kidney disease without WMT in the past three months * Able to tolerate colonoscopy * Receiving rescue FMT from the China Microbiota Transplantation System * Suitable and compatible with WMT treatment * Patients who can fully understand the content of informed consent for this trial and voluntarily sign a written informed consent form * Able to receive follow-up examinations, follow-up examinations and retain specimens on time
Exclusion criteria
* Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT * Antibiotics or probiotics within 4 weeks prior to enrollment * Patients with anxiety, depression, mental or legal disabilities * Patients with fulminant type, massive bloody stools, and severe illness unable to tolerate colonoscopy * Other patients deemed unsuitable for enrollment by the investigator
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Blood Creatinine | 1 week, 4 week, 12 week | Patients' Laboratory Change from Baseline Blood Creatinine |
| Changes in 24-hour Urine Protein | 1 week, 4 week, 12 week | Patients' Laboratory Change from Changes in 24-hour urine protein |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adverse Events | 4 week, 12 week following WMT | The rate of adverse events after Washed microbiota transplantation |
Countries
China
Contacts
Primary ContactFaming Zhang
Outcome results
None listed