Clinical trial NCT03648086: Intestinal Microbiota Transplantation for Nonalcoholic Fatty Liver Disease
Official title: Efficacy, Safety of Intestinal Microbiota Transplantation for Nonalcoholic Fatty Liver Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: NAFLD
Lead sponsor: Zhongshan Hospital Xiamen University
Sponsor class: OTHER
First posted: 2018-08-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: an open label, parallel study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change of CT ratio of liver/spleen
timeFrame: 3 months, 6months
Secondary outcomes:
measure: biochemical indicators
timeFrame: 3 months, 6months
measure: Fibroscan E value
timeFrame: 3 months, 6 months
measure: Changes of gut microbiota
timeFrame: 3 months, 6months
Other outcomes:
Locations:
city: Xiamen
country: China
facility: Zhongshan Hospital Affiliated to Xiamen University
state: Fujian
Study officials:
References: