Intestinal Microbiota Transplantation for Nonalcoholic Fatty Liver Disease (NAFLD)
2018年8月22日 更新者：Zhongshan Hospital Xiamen University
Efficacy, Safety of Intestinal Microbiota Transplantation for Nonalcoholic Fatty Liver Disease
In China, with the improvement of living standards, there is a significant increase in the rate of prevalence of type 2 diabetes and hyperlipidemia, associated with Non-alcoholic fatty liver disease（NAFLD） which has gradually become a major public health problem in our country.
The latest study found that intestinal microflora imbalance is closely correlated with NAFLD.
In this subject, the investigators aim to explore whether intestinal microbiota transplantation(IMT) could reverse the change of intestinal microflora imbalance and has direct effects of NAFLD.
研究概览
详细说明
Non-alcoholic fatty liver disease (NAFLD) is a significant health problem.
With the trend of obesity and associated metabolic syndrome globally, nonalcoholic fatty liver disease has become a high incidence of liver disease in developed countries, the prevalence rate of NAFLD adult is about 10% ~ 30%.
Therefore, effective prevention and treatment of NAFLD has important significance in improving people's quality of life and disease prognosis.
The latest study found that intestinal microflora imbalance is closely correlated with NAFLD.
When the structure of intestinal flora is destroyed, host energy absorption and storage of fat balance will be broken, with higher absorption of efficiency.
At the same time, metabolic disorder expands.
In this projects the investigators aim to re-establish a gut balance of intestinal microbiota through Standardized Intestinal Microbiota Transplantation for NAFLD.
The CT ratio of liver/spleen, Fibroscan E value, general indicators, biochemical indicators will be used to assess the efficiency, durability and safety of Standardized IMT at the start and end of the projects.
研究类型
介入性
注册 (预期的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Fujian
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Xiamen、Fujian、中国、361000
- 招聘中
- Zhongshan Hospital Affiliated to Xiamen University
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接触：
- Ynag Song
- 电话号码：18559666260
- 邮箱：tcsongyang@sina.com
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 至 65年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- subjects with NAFLD(nonalcoholic fatty liver disease)
- aged 18-65
- 24≤BMI
- liver/spleen (L/S) ratio no more than 0.7 by CT scan
Exclusion Criteria:
- Alcoholic liver disease (ALD), chronic hepatitis C, autoimmune liver disease, Wilson's disease
- Drug treatment (tamoxifen, amiodarone, sodium valproate, methotrexate, glucocorticoids, etc.), total parenteral nutrition, inflammatory bowel disease, hypothyroidism, Cushing's syndrome, beta lipoprotein deficiency, IR related syndromes (lipid wasting diabetes mellitus, Mauriac syndrome), gastrointestinal surgery
- Hepatocellular carcinoma (HCC), biliary tract diseases and taking or taking chinese and western medicines that can lead liver enzymes elevation in the near future.
- Moderate and severe renal injuty(serum creatinine>2mg/dL or 177mmol/L), moderate and severe chronic obstructive pulmonary disease, severe hypertension, cerebrovascular accident, congestive heart failure, unstable angina pectoris.
- Antibiotics treatment in 7 days before recruited and unwilling to stop it, long-term lipid-lowering drugs, antidiabetic drugs and other liver protecting drugs treatment
- Antibiotics, other probiotics, gastrointestinal motility drugs and other preparation that may influence intestinal microbiota treatment
- Other serious diseases that may interfere the recruitment or affect the survival, such as cancer or acquired immune deficiency syndrome
- Mentally or legally disabled person
- Preparing for pregnancy
- Medical or social condition which in the opinion of the principal investigator would interfere with or prevent regular follow up
- Participating in other clinical trials.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：IMT
30 non-alcoholic fatty liver disease（NAFLD） patients will be recruited for the study, which involved a 6 times intestinal microbiota transplant(IMT) and the time interval is generally 2 weeks.
|
Participants in Exprerimental group take 6 times IMT with 2-week intervals
其他名称：
|
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无干预：control
30 non-alcoholic fatty liver disease(NAFLD) patients without any treatment
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The change of CT ratio of liver/spleen
大体时间：3 months, 6months
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CT imaging has been used to assess hepatic steatosis and has been validated in relation to liver biopsy .The ratio of liver to spleen (L/S ratio) for CT attenuation values is an index, with a L/S ratio<1 considered to represent fatty liver .The change of CT ratio of liver/spleen will be assessed at different time comparing with the baseline.
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3 months, 6months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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biochemical indicators
大体时间：3 months, 6months
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Liver function such as ALT,AST,ALT/AST will be assessed at different time comparing with the baseline.
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3 months, 6months
|
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Fibroscan E value
大体时间：3 months, 6 months
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Fibroscan E value is a indicators for evaluating liver fibrosis.Changes will be assessed at different time comparing with the baseline.
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3 months, 6 months
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Changes of gut microbiota
大体时间：3 months, 6months
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Alpha and Beta diversity of GI microbiota by High-throughput sequencing on baseline line and 3 months, 6months after treatment
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3 months, 6months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年11月14日
初级完成 (预期的)
2020年10月1日
研究完成 (预期的)
2020年11月1日
研究注册日期
首次提交
2017年10月25日
首先提交符合 QC 标准的
2018年8月22日
首次发布 (实际的)
2018年8月27日
研究记录更新
最后更新发布 (实际的)
2018年8月27日
上次提交的符合 QC 标准的更新
2018年8月22日
最后验证
2017年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.