Washed Microbiota Transplantation (WMT) for Chronic Kidney Disease (CKD): a Open Label, Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Changes in 24-hour Urine Protein
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 16 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Standard of Care for Chronic Kidney Disease
干预措施: Standard of Care for Chronic Kidney Disease (Other)
Washed Microbiota Transplantation to treat Chronic Kidney Disease
干预措施: Fecal Microbiota Transplantation (Drug)
结局指标
主要结局
Changes in 24-hour Urine Protein
时间窗: 1 week, 4 week, 12 week
Patients' Laboratory Change from Changes in 24-hour urine protein
Changes in Blood Creatinine
时间窗: 1 week, 4 week, 12 week
Patients' Laboratory Change from Baseline Blood Creatinine
次要结局
未报告次要终点