Implications of Fecal Microbiota Transplantation in Modulating the Effects of Liver Cirrhosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 19
- 试验地点
- 2
- 主要终点
- Implications of fecal microbiota transplantation in modulating the effects of liver cirrhosis.
研究概览
简要总结
The study aims to investigate the beneficial effects of fecal transplantation in patients diagnosed with liver cirrhosis (regardless of etiology).
详细描述
Participants in the experimental group will receive fecal microbiota transplantation (FMT) from a screened healthy donor. Each patient will undergo colonoscopic delivery of a minimum of 70 grams of donor fecal material into the cecum. The study will assess outcomes by monitoring clinical status, laboratory tests, imaging results and stool analyses (including assessment of micro-RNA profiles), comparing changes from baseline and with the control group. Participants will undergo scheduled re-evaluations at approximately 1 month post-transplant (timing may vary slightly due to clinical or logistical considerations).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of liver cirrhosis according to current protocols.
- •Conscious and cooperative adult patients.
排除标准
- •Patients with hemodynamic and/or respiratory instability.
- •Patients with contraindications for colonoscopy or fecal transplantation.
- •Patients with acute or chronic infections with HIV, Tuberculosis, MDR Enterobacteria, CMV, parasites, fungi.
- •Associated oncological pathology.
- •Patients with other causes of severe immunodeficiencies.
- •Lack of compliance with the conditions imposed by the research project.
- •Patients who do not sign the informed consent.
结局指标
主要结局
Implications of fecal microbiota transplantation in modulating the effects of liver cirrhosis.
时间窗: Up to 3 months
The transfer of microbiota could potentially influence hepatic fibrosis via the gut-liver axis, as well as other complications caused by cirrhosis such as encephalopathy, ascites etc.
Implications of fecal microbiota transplantation in modulating the condition of other organs.
时间窗: Up to 3 months
The transfer of microbiota could potentially modulate the function of other major organs in the body.
次要结局
未报告次要终点
研究者
Cristian Ichim
Principal Investigator
Academic Emergency County Hospital Sibiu