NCT05838118

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: The Second Hospital of Nanjing Medical University · Academic / Other
• Sex: All
• Age: 16 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• CKD

Interventions

Type	Name	Description
DRUG	Fecal Microbiota Transplantation	Biologically active human fecal fluid (donor stool) is provided in fluid form.
OTHER	Standard of Care for Chronic Kidney Disease	Patients accepted oral drug or dialytic therapy like they used to be to treat CKD.

Timeline

• Start date: 2023-04-20
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2023-05-01
• Last updated: 2023-05-01

Locations

1 site across 1 country: China