Clinical trial NCT05838118: Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD)
Official title: Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD): a Open Label, Multicenter Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: CKD
Keywords: Fecal Microbiota Transplantation (FMT)
Chronic Kidney Disease (CKD)
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-05-01
Enrollment: 100
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in Blood Creatinine
timeFrame: 1 week, 4 week, 12 week
measure: Changes in 24-hour Urine Protein
timeFrame: 1 week, 4 week, 12 week
Secondary outcomes:
Other outcomes:
measure: Rate of Adverse Events
timeFrame: 4 week, 12 week following WMT
Locations:
city: Nanjing
country: China
facility: the Second Affiliated of Nanjing Medical University
state: Jiangsu
Study officials:
References:
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 and chronic kidney disease. Cell Metab. 2021 Oct 5;33(10):2091-2093. doi: 10.1016/j.cmet.2021.08.015. No abstract available.
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: 10.1038/s41598-017-01387-y.
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.
citation: 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.