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

NCT05838118 | Unknown

• 1 other identifier: FamingZhang
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

CKD

Keywords

Fecal Microbiota Transplantation (FMT); Chronic Kidney Disease (CKD)

Outcome Measures

Primary Outcomes (2)

• Changes in Blood Creatinine

  Patients' Laboratory Change from Baseline Blood Creatinine

  1 week, 4 week, 12 week

• Changes in 24-hour Urine Protein

  Patients' Laboratory Change from Changes in 24-hour urine protein

  1 week, 4 week, 12 week

Other Outcomes (1)

• Rate of Adverse Events

  4 week, 12 week following WMT

Study Arms (2)

Washed Microbiota Transplantation to treat Chronic Kidney Disease

OTHER

Drug: Fecal Microbiota Transplantation

Standard of Care for Chronic Kidney Disease

OTHER

Other: Standard of Care for Chronic Kidney Disease

Interventions

Fecal Microbiota Transplantation DRUG

Biologically active human fecal fluid (donor stool) is provided in fluid form.

Washed Microbiota Transplantation to treat Chronic Kidney Disease

Standard of Care for Chronic Kidney Disease OTHER

Patients accepted oral drug or dialytic therapy like they used to be to treat CKD.

Standard of Care for Chronic Kidney Disease

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Second Hospital of Nanjing Medical University: lead

Study Sites (1)

the Second Affiliated of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

RECRUITING

Related Publications (4)

• Zhu H, Cao C, Wu Z, Zhang H, Sun Z, Wang M, Xu H, Zhao Z, Wang Y, Pei G, Yang Q, Zhu F, Yang J, Deng X, Hong Y, Li Y, Sun J, Zhu F, Shi M, Qian K, Ye T, Zuo X, Zhao F, Guo J, Xu G, Yao Y, Zeng R. The probiotic L. casei Zhang slows the progression of acute and chronic kidney disease. Cell Metab. 2021 Oct 5;33(10):2091-2093. doi: 10.1016/j.cmet.2021.08.015. No abstract available.

  PMID: 34614411 RESULT

• Xu KY, Xia GH, Lu JQ, Chen MX, Zhen X, Wang S, You C, Nie J, Zhou HW, Yin J. Impaired renal function and dysbiosis of gut microbiota contribute to increased trimethylamine-N-oxide in chronic kidney disease patients. Sci Rep. 2017 May 3;7(1):1445. doi: 10.1038/s41598-017-01387-y.

  PMID: 28469156 RESULT

• Xu L, Guo J, Moledina DG, Cantley LG. Immune-mediated tubule atrophy promotes acute kidney injury to chronic kidney disease transition. Nat Commun. 2022 Aug 19;13(1):4892. doi: 10.1038/s41467-022-32634-0.

  PMID: 35986026 RESULT

• Lu J, Chen PP, Zhang JX, Li XQ, Wang GH, Yuan BY, Huang SJ, Liu XQ, Jiang TT, Wang MY, Liu WT, Ruan XZ, Liu BC, Ma KL. GPR43 deficiency protects against podocyte insulin resistance in diabetic nephropathy through the restoration of AMPKalpha activity. Theranostics. 2021 Mar 4;11(10):4728-4742. doi: 10.7150/thno.56598. eCollection 2021.

  PMID: 33754024 RESULT

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Interventions

Fecal Microbiota Transplantation; Standard of Care

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biological Therapy; Therapeutics; Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Central Study Contacts

Faming Zhang

CONTACT

02556662092; fzhang@njmu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 8, 2023
• First Posted: May 1, 2023
• Study Start: April 20, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 1, 2023

Record last verified: 2023-01

Locations

CN (1)