Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD)

Study Overview
=================
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.

Official Title
-----------------
Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD): a Open Label, Multicenter Trial

Conditions
-----------------
CKD

Intervention / Treatment
-----------------
* Drug: Fecal Microbiota Transplantation
* Other: Standard of Care for Chronic Kidney Disease


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Washed Microbiota Transplantation to treat Chronic Kidney Disease<br> | Drug: Fecal Microbiota Transplantation<br>* Biologically active human fecal fluid (donor stool) is provided in fluid form.<br>|
| Other: Standard of Care for Chronic Kidney Disease<br> | Other: Standard of Care for Chronic Kidney Disease<br>* Patients accepted oral drug or dialytic therapy like they used to be to treat CKD.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Blood Creatinine | Patients' Laboratory Change from Baseline Blood Creatinine | 1 week, 4 week, 12 week | 
| Changes in 24-hour Urine Protein | Patients' Laboratory Change from Changes in 24-hour urine protein | 1 week, 4 week, 12 week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fecal Microbiota Transplantation (FMT), Chronic Kidney Disease (CKD)