NCT_ID: NCT05838118
Clinical Trial Link
Brief Summaries
| Sequence: | 30563887 |
| Description | 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. |
Studies
| Study First Submitted Date | 2023-04-08 |
| Study First Posted Date | 2023-05-01 |
| Last Update Posted Date | 2023-05-01 |
| Start Month Year | April 20, 2023 |
| Primary Completion Month Year | December 31, 2024 |
| Verification Month Year | January 2023 |
| Verification Date | 2023-01-31 |
| Last Update Posted Date | 2023-05-01 |
Detailed Descriptions
| Sequence: | 20587447 |
| 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. |
Facilities
| Sequence: | 198729097 |
| Status | Recruiting |
| Name | the Second Affiliated of Nanjing Medical University |
| City | Nanjing |
| State | Jiangsu |
| Zip | 210011 |
| Country | China |
Facility Contacts
| Sequence: | 27954933 |
| Facility Id | 198729097 |
| Contact Type | primary |
| Name | Faming Zhang |
| fzhang@njmu.edu.cn | |
| Phone | 02556662092 |
Conditions
| Sequence: | 51825575 |
| Name | CKD |
| Downcase Name | ckd |
Id Information
| Sequence: | 39883019 |
| Id Source | org_study_id |
| Id Value | FamingZhang |
Countries
| Sequence: | 42281514 |
| Name | China |
| Removed | False |
Design Groups
| Sequence: | 55248402 | Sequence: | 55248403 |
| Group Type | Other | Group Type | Other |
| Title | Washed Microbiota Transplantation to treat Chronic Kidney Disease | Title | Standard of Care for Chronic Kidney Disease |
Interventions
| Sequence: | 52146941 | Sequence: | 52146942 |
| Intervention Type | Drug | Intervention Type | Other |
| Name | Fecal Microbiota Transplantation | Name | Standard of Care for Chronic Kidney Disease |
| Description | Biologically active human fecal fluid (donor stool) is provided in fluid form. | Description | Patients accepted oral drug or dialytic therapy like they used to be to treat CKD. |
Keywords
| Sequence: | 79304507 | Sequence: | 79304508 |
| Name | Fecal Microbiota Transplantation (FMT) | Name | Chronic Kidney Disease (CKD) |
| Downcase Name | fecal microbiota transplantation (fmt) | Downcase Name | chronic kidney disease (ckd) |
Design Outcomes
| Sequence: | 176258994 | Sequence: | 176258995 | Sequence: | 176258996 |
| Outcome Type | primary | Outcome Type | primary | Outcome Type | other |
| Measure | Changes in Blood Creatinine | Measure | Changes in 24-hour Urine Protein | Measure | Rate of Adverse Events |
| Time Frame | 1 week, 4 week, 12 week | Time Frame | 1 week, 4 week, 12 week | Time Frame | 4 week, 12 week following WMT |
| Description | Patients' Laboratory Change from Baseline Blood Creatinine | Description | Patients' Laboratory Change from Changes in 24-hour urine protein | Description | The rate of adverse events after Washed microbiota transplantation |
Browse Conditions
| Sequence: | 192093404 | Sequence: | 192093405 | Sequence: | 192093406 | Sequence: | 192093407 | Sequence: | 192093408 | Sequence: | 192093409 | Sequence: | 192093410 | Sequence: | 192093411 | Sequence: | 192093412 | Sequence: | 192093413 | Sequence: | 192093414 |
| Mesh Term | Kidney Diseases | Mesh Term | Renal Insufficiency, Chronic | Mesh Term | Urologic Diseases | Mesh Term | Female Urogenital Diseases | Mesh Term | Female Urogenital Diseases and Pregnancy Complications | Mesh Term | Urogenital Diseases | Mesh Term | Male Urogenital Diseases | Mesh Term | Renal Insufficiency | Mesh Term | Chronic Disease | Mesh Term | Disease Attributes | Mesh Term | Pathologic Processes |
| Downcase Mesh Term | kidney diseases | Downcase Mesh Term | renal insufficiency, chronic | Downcase Mesh Term | urologic diseases | Downcase Mesh Term | female urogenital diseases | Downcase Mesh Term | female urogenital diseases and pregnancy complications | Downcase Mesh Term | urogenital diseases | Downcase Mesh Term | male urogenital diseases | Downcase Mesh Term | renal insufficiency | Downcase Mesh Term | chronic disease | Downcase Mesh Term | disease attributes | Downcase Mesh Term | pathologic processes |
| Mesh Type | mesh-list | Mesh Type | mesh-list | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor | Mesh Type | mesh-ancestor |
Sponsors
| Sequence: | 47997854 |
| Agency Class | OTHER |
| Lead Or Collaborator | lead |
| Name | The Second Hospital of Nanjing Medical University |
Central Contacts
| Sequence: | 11938405 |
| Contact Type | primary |
| Name | Faming Zhang |
| Phone | 02556662092 |
| fzhang@njmu.edu.cn | |
| Role | Contact |
Design Group Interventions
| Sequence: | 67731927 | Sequence: | 67731928 |
| Design Group Id | 55248402 | Design Group Id | 55248403 |
| Intervention Id | 52146941 | Intervention Id | 52146942 |
Eligibilities
| Sequence: | 30562668 |
| Gender | All |
| Minimum Age | 16 Years |
| Maximum Age | 65 Years |
| Healthy Volunteers | No |
| 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 |
| Adult | True |
| Child | True |
| Older Adult | True |
Calculated Values
| Sequence: | 254249922 |
| Number Of Facilities | 1 |
| Registered In Calendar Year | 2023 |
| Were Results Reported | False |
| Has Us Facility | False |
| Has Single Facility | True |
| Minimum Age Num | 16 |
| Maximum Age Num | 65 |
| Minimum Age Unit | Years |
| Maximum Age Unit | Years |
| Number Of Primary Outcomes To Measure | 2 |
| Number Of Other Outcomes To Measure | 1 |
Designs
| Sequence: | 30310951 |
| Allocation | Non-Randomized |
| Intervention Model | Parallel Assignment |
| Observational Model | |
| Primary Purpose | Treatment |
| Time Perspective | |
| Masking | None (Open Label) |
Responsible Parties
| Sequence: | 28689584 |
| Responsible Party Type | Sponsor |
Study References
| Sequence: | 51719397 | Sequence: | 51719398 | Sequence: | 51719399 | Sequence: | 51719400 |
| Pmid | 34614411 | Pmid | 28469156 | Pmid | 35986026 | Pmid | 33754024 |
| Reference Type | result | Reference Type | result | Reference Type | result | Reference Type | result |
| 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. |