NCT06166667已完成不适用
Effect of Fecal Capsule on Chronic Kidney Disease (CKD)
Shanxi Provincial People's Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2023年3月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Abundance of gut microbiota
研究概览
简要总结
By collecting blood, urine and stool samples before and after oral Enterobacteriaceae capsule (FMT) from CKD subjects, we investigated the role and related mechanisms of gut microecology in the development of CKD using a combination of metagenomic sequencing, metabolomic analysis and flow cytometry.
详细描述
Patients involved in the trial received 16 capsules of Enterobacteriaceae (one course) on days 1, 8, and 15, which were provided by Dongyuan Yikang company. Patients were prohibited from taking antibiotics such as amoxicillin and Cefalexin during the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects: Patients with chronic kidney disease (CKD)
- •GFR ≥ 30 ml / min, or serum creatinine ≤ 442 μ mol/L
- •Negative urine pregnancy test and no plans for pregnancy for the next 18 months, enabling effective contraception
- •Age: 18-70 years
- •Signed informed consent for clinical studies informed consent for treatment of patients with flora transplantation (FMT)
排除标准
- •Had taken antibiotics for nearly 14 days
- •Active systemic infections or severe infections within 1 month prior to enrollment, including HIV, HBV, HCV
- •White blood cell count < 3.0x109/l; Platelet count < 80x109 / L, or had other hematologic diseases
- •Presence of malignancy and other diseases with expected survival time < 3 months
- •Presence of IBD, CDI, or gastrointestinal tumors
- •Presence of active gastrointestinal bleeding or acute and chronic gastrointestinal inflammation
- •Were or had undergone FMT
- •Psychosis and cognitive impairment
- •History of alcohol or drug abuse
- •Pregnant or lactating women
- •Difficult to follow-up
- •Difficult or unwilling to cooperate
研究组 & 干预措施
experimental group
Experimental
Fecal Microbiota Transplant
干预措施: Fecal Microbiota Transplant（FMT） (Procedure)
结局指标
主要结局
Abundance of gut microbiota
时间窗: 6 months after the end of the trial
Fecal sample metagenomic sequencing
次要结局
- 24-hour urine protein quantitative change rate(6 months after the end of the trial)
- the density of immune cells(6 months after the end of the trial)
- Cytokine concentration(6 months after the end of the trial)
研究者
研究点 (1)
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