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

CKD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05838118
• Other study ID #: FamingZhang
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2023
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2023
• Source: The Second Hospital of Nanjing Medical University
• Contact: Faming Zhang
• Phone: 02556662092
• Email: fzhang[@]njmu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• CKD
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

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.

Locations

Country	Name	City	State
China	the Second Affiliated of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
The Second Hospital of Nanjing Medical University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. The — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Rate of Adverse Events	The rate of adverse events after Washed microbiota transplantation	4 week, 12 week following WMT
Primary	Changes in Blood Creatinine	Patients' Laboratory Change from Baseline Blood Creatinine	1 week, 4 week, 12 week
Primary	Changes in 24-hour Urine Protein	Patients' Laboratory Change from Changes in 24-hour urine protein	1 week, 4 week, 12 week