Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Other: Washed Microbiota Transplantation to treat Chronic Kidney Disease
|
Drug: Fecal Microbiota Transplantation
Biologically active human fecal fluid (donor stool) is provided in fluid form.
|
| Other: Standard of Care for Chronic Kidney Disease
|
Other: Standard of Care for Chronic Kidney Disease
Patients accepted oral drug or dialytic therapy like they used to be to treat CKD.
|
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- Rate of Adverse Events [4 week, 12 week following WMT]
The rate of adverse events after Washed microbiota transplantation
Eligibility Criteria
Criteria
Inclusion Criteria:
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Being diagnosed with chronic kidney disease without WMT in the past three months
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Able to tolerate colonoscopy
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Receiving rescue FMT from the China Microbiota Transplantation System
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Suitable and compatible with WMT treatment
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Patients who can fully understand the content of informed consent for this trial and voluntarily sign a written informed consent form
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Able to receive follow-up examinations, follow-up examinations and retain specimens on time
Exclusion Criteria:
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Patients will be excluded from the analysis if they are not followed up for at least 12 weeks post-FMT
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Antibiotics or probiotics within 4 weeks prior to enrollment
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Patients with anxiety, depression, mental or legal disabilities
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Patients with fulminant type, massive bloody stools, and severe illness unable to tolerate colonoscopy
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Other patients deemed unsuitable for enrollment by the investigator
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | the Second Affiliated of Nanjing Medical University | Nanjing | Jiangsu | China | 210011 |
Sponsors and Collaborators
- The Second Hospital of Nanjing Medical University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FamingZhang