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

Last updated: April 20, 2023
Sponsor: The Second Hospital of Nanjing Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

Fecal Microbiota Transplantation

Standard of Care for Chronic Kidney Disease

Clinical Study ID

NCT05838118
FamingZhang
  • Ages 16-65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 andvoluntarily sign a written informed consent form
  • Able to receive follow-up examinations, follow-up examinations and retain specimens ontime

Exclusion

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 totolerate colonoscopy
  • Other patients deemed unsuitable for enrollment by the investigator

Study Design

Total Participants: 100
Treatment Group(s): 2
Primary Treatment: Fecal Microbiota Transplantation
Phase:
Study Start date:
April 20, 2023
Estimated Completion Date:
December 31, 2024

Study 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.

Connect with a study center

  • the Second Affiliated of Nanjing Medical University

    Nanjing, Jiangsu 210011
    China

    Active - Recruiting

+−

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.