Clinical trial
Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD): a Open Label, Multicenter Trial
Name
FamingZhang
Description
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.
Trial arms
Trial start
2023-04-20
Estimated PCD
2024-12-31
Trial end
2024-12-31
Status
Recruiting
Treatment
Fecal Microbiota Transplantation
Biologically active human fecal fluid (donor stool) is provided in fluid form.
Arms:
Washed Microbiota Transplantation to treat Chronic Kidney Disease
Standard of Care for Chronic Kidney Disease
Patients accepted oral drug or dialytic therapy like they used to be to treat CKD.
Arms:
Standard of Care for Chronic Kidney Disease
Size
100
Primary endpoint
Changes in Blood Creatinine
1 week, 4 week, 12 week
Changes in 24-hour Urine Protein
1 week, 4 week, 12 week
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 100, 'type': 'ESTIMATED'}}
Updated at
2023-05-01
1 organization
1 product
1 indication
Indication
Chronic Kidney Disease