Viewing Study NCT05838118


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Study NCT ID: NCT05838118
Status: UNKNOWN
Last Update Posted: 2023-05-01
First Post: 2023-04-08
Is NOT Gene Therapy: False
Has Adverse Events: False

Brief Title: Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD)
Sponsor: The Second Hospital of Nanjing Medical University
Organization:

Study Overview

Official Title: Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD): a Open Label, Multicenter Trial
Status: UNKNOWN
Status Verified Date: 2023-01
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
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.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: