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

Nanjing Medical University

Status

Enrolling

Conditions

CKD

Treatments

Drug: Fecal Microbiota Transplantation

Other: Standard of Care for Chronic Kidney Disease

Study type

Interventional

Funder types

Other

Identifiers

NCT05838118

FamingZhang

Details and patient eligibility

About

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.

Full 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.

Enrollment

100 estimated patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

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