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Intestinal Microbiota Transplantation for Nonalcoholic Fatty Liver Disease (NAFLD)

Primary Purpose

Non-alcoholic Fatty Liver Disease

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
intestinal microbiota transplantation
Sponsored by
Zhongshan Hospital Xiamen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-alcoholic Fatty Liver Disease focused on measuring NAFLD

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Zhongshan Hospital Affiliated to Xiamen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

IMT

control

Arm Description

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.

30 non-alcoholic fatty liver disease(NAFLD) patients without any treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
October 25, 2017
Last Updated
August 22, 2018
Sponsor
Zhongshan Hospital Xiamen University
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1. Study Identification

Unique Protocol Identification Number
NCT03648086
Brief Title
Intestinal Microbiota Transplantation for Nonalcoholic Fatty Liver Disease
Acronym
NAFLD
Official Title
Efficacy, Safety of Intestinal Microbiota Transplantation for Nonalcoholic Fatty Liver Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
November 14, 2017 (Actual)
Primary Completion Date
October 2020 (Anticipated)
Study Completion Date
November 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zhongshan Hospital Xiamen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-alcoholic Fatty Liver Disease
Keywords
NAFLD

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
an open label, parallel study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IMT
Arm Type
Experimental
Arm Description
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.
Arm Title
control
Arm Type
No Intervention
Arm Description
30 non-alcoholic fatty liver disease(NAFLD) patients without any treatment
Intervention Type
Other
Intervention Name(s)
intestinal microbiota transplantation
Other Intervention Name(s)
IMT
Intervention Description
Participants in Exprerimental group take 6 times IMT with 2-week intervals
Primary Outcome Measure Information:
Title
The change of CT ratio of liver/spleen
Description
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.
Time Frame
3 months, 6months
Secondary Outcome Measure Information:
Title
biochemical indicators
Description
Liver function such as ALT,AST,ALT/AST will be assessed at different time comparing with the baseline.
Time Frame
3 months, 6months
Title
Fibroscan E value
Description
Fibroscan E value is a indicators for evaluating liver fibrosis.Changes will be assessed at different time comparing with the baseline.
Time Frame
3 months, 6 months
Title
Changes of gut microbiota
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yang Song
Phone
18559666260
Email
tcsongyang@sina.com
Facility Information:
Facility Name
Zhongshan Hospital Affiliated to Xiamen University
City
Xiamen
State/Province
Fujian
ZIP/Postal Code
361000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ynag Song
Phone
18559666260
Email
tcsongyang@sina.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Intestinal Microbiota Transplantation for Nonalcoholic Fatty Liver Disease

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