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

Not Applicable

Recruiting

• Conditions: CKD
• Interventions: Drug: Fecal Microbiota Transplantation; Other: Standard of Care for Chronic Kidney Disease

• Registration Number: NCT05838118
• Lead Sponsor: The Second Hospital of Nanjing Medical University

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 Timeline

• Status Verified: 2023-01
• Study First Submitted: 2023-04-08
• Study Start: 2023-04-20
• Study First Submitted QC: 2023-04-20
• Last Update Submitted: 2023-04-20
• Study First Posted: 2023-05-01
• Last Update Posted: 2023-05-01
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Washed Microbiota Transplantation to treat Chronic Kidney Disease	Fecal Microbiota Transplantation	-
Standard of Care for Chronic Kidney Disease	Standard of Care for Chronic Kidney Disease	-

Primary Outcome Measures

Name	Time	Method
Changes in Blood Creatinine	1 week, 4 week, 12 week	Patients' Laboratory Change from Baseline Blood Creatinine
Changes in 24-hour Urine Protein	1 week, 4 week, 12 week	Patients' Laboratory Change from Changes in 24-hour urine protein

Trial Locations

Locations (1)

the Second Affiliated of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China