Intestinal Microbiota Transplantation for Nonalcoholic Fatty Liver Disease (NAFLD)

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.

Study Overview

• Status: Unknown
• Conditions: Non-alcoholic Fatty Liver Disease
• Intervention / Treatment: Other: intestinal microbiota transplantation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Xiamen, Fujian, China, 361000
      • Recruiting
      • Zhongshan Hospital Affiliated to Xiamen University
      • Contact: Ynag Song; Phone Number: 18559666260; Email: tcsongyang@sina.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: intestinal microbiota transplantation; Participants in Exprerimental group take 6 times IMT with 2-week intervals; Other Names: IMT
No Intervention: control; 30 non-alcoholic fatty liver disease(NAFLD) patients without any treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 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.	3 months, 6months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
biochemical indicators	Liver function such as ALT,AST,ALT/AST will be assessed at different time comparing with the baseline.	3 months, 6months
Fibroscan E value	Fibroscan E value is a indicators for evaluating liver fibrosis.Changes will be assessed at different time comparing with the baseline.	3 months, 6 months
Changes of gut microbiota	Alpha and Beta diversity of GI microbiota by High-throughput sequencing on baseline line and 3 months, 6months after treatment	3 months, 6months

Collaborators and Investigators

• Sponsor: Zhongshan Hospital Xiamen University

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2017
• Primary Completion (Anticipated): October 1, 2020
• Study Completion (Anticipated): November 1, 2020

Study Registration Dates

• First Submitted: October 25, 2017
• First Submitted That Met QC Criteria: August 22, 2018
• First Posted (Actual): August 27, 2018

Study Record Updates

• Last Update Posted (Actual): August 27, 2018
• Last Update Submitted That Met QC Criteria: August 22, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: NAFLD
• Additional Relevant MeSH Terms: Digestive System Diseases; Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease
• Other Study ID Numbers: 2017005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No