Efficacy, Safety of Intestinal Microbiota Transplantation for Nonalcoholic Fatty Liver Disease
Phase: NA
Conditions: Non-alcoholic Fatty Liver Disease
Sponsor: Zhongshan Hospital Xiamen University

Intestinal Microbiota
Transplantation for Nonalcoholic
Fatty Liver Disease (NAFLD)
Date:2017.5

1.Method
Intestinal microbiota transplantation(IMT) refers to make fecal from the health
into a suspension of microbes through an intelligent bacteria processing system, and
then infuse the suspension into the gastrointestinal tract of patients through naso
intestinal tube, gastroscope, enteroscope or capsule intake which can reconstruct
intestinal microbiota and play the role of treatment without obvious side effect.
2.Plan
1)Patient recruitment
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 injury (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 articipating in other clinical trials.
Recruit the patients who meet the inclusion criteria, and fail to meet the exclusion

criteria. Introduce this clinical trial to the patients and obtain the informed consent.
Assess the condition of the disease.
2)Arms and Interventions
Randomly divided the patients into experimental arm and control arm and
intervene them as described in the following table.
arms
Assigned interventions
Experimental: 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.
Interventions:
Procedure: Intestinal Microbiota
Transplantation
intestinal microbiota transplant
intestinal microbiota transplantation
Participants in Experimental group
take 6 times IMT with 2-week intervals
Agents
30 non-alcoholic fatty liver disease
(NAFLD) patients without any treatment
3)Outcome Measures
Primary Outcome Measure:
1
The change of CT ratio of liver/spleen
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
attenuationvalues is an index, with a L/S ratio<1 considered to represent
fatty liver. The
2
change of CT ratio of liver/spleen will be assessed at different time
comparing with the baseline.
Secondary Outcome Measure:
1
general indicators
Basic information and symptoms will be assessed at
different time comparing with the baseline
[Time Frame: 3 months, 6months]
2
biochemical indicators

Liver function will be assessed at different time comparing with the
baseline
[Time Frame: 3 months, 6months]
3
Fibroscan E value
Fibroscan E value is indicators for evaluating liver fibrosis. Changes will be
assessed at different time comparing with the baseline
[Time Frame: 3 months, 6months]
4
Changes of gut microbiota
Alpha and Beta diversity of GI microbiota by High-throughput sequencing
on baseline
line and 3 months,6months after treatment.
[Time Frame: 3 months, 6months]