Intestinal Microbiota Transplantation for Nonalcoholic Fatty Liver Disease

NCT ID: NCT03648086

Last Updated: 2018-08-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-14
• Study Completion Date: 2020-11-30

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.

Conditions

Non-alcoholic Fatty Liver Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

intestinal microbiota transplantation

Intervention Type: OTHER

Participants in Exprerimental group take 6 times IMT with 2-week intervals

control

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

intestinal microbiota transplantation

Participants in Exprerimental group take 6 times IMT with 2-week intervals

Intervention Type: OTHER

Other Intervention Names

IMT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zhongshan Hospital Xiamen University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital Affiliated to Xiamen University

Xiamen, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yang Song

Role: CONTACT

tcsongyang@sina.com

18559666260

Facility Contacts

Ynag Song

Role: primary

tcsongyang@sina.com

18559666260

Provided Documents

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2017005

Identifier Type: -

Identifier Source: org_study_id