Non-alcoholic Fatty Liver DiseaseNAFLDNCT03648086
Intestinal Microbiota Transplantation for Nonalcoholic Fatty Liver Disease
A study testing intestinal microbiota transplantation in people with Non-alcoholic Fatty Liver Disease, run by Zhongshan Hospital Xiamen University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Non-alcoholic Fatty Liver Disease
- What is being tested?
- intestinal microbiota transplantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 14 Nov 2017to Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, 361000
Ynag Song, 18559666260, tcsongyang@sina.com
About this study
Official title: 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.
Read the 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
- Being tested
- intestinal microbiota transplantation
- Keywords
- NAFLD
- Medical subject headings
- Non-alcoholic Fatty Liver Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
intestinal microbiota transplantationOther
Also called IMT
Participants in Exprerimental group take 6 times IMT with 2-week intervals
| Study group | Role | What they receive |
|---|---|---|
| IMT | Experimental | 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. Receives: Other: intestinal microbiota transplantation |
| control | No intervention | 30 non-alcoholic fatty liver disease(NAFLD) patients without any treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months, 6months
Secondary outcomes (3)
biochemical indicators
Liver function such as ALT,AST,ALT/AST will be assessed at different time comparing with the baseline.
Measured: 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.
Measured: 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
Measured: 3 months, 6months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2018
- Study start14 Nov 2017
- Primary completionOct 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-alcoholic Fatty Liver DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- an open label, parallel study
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhongshan Hospital Xiamen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03648086
- Sponsor's protocol ID
- 2017005
- Acronym
- NAFLD
- Status last verified
- Oct 2017
- First submitted
- 25 Oct 2017
- Last updated
- 27 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy, Safety of Intestinal Microbiota Transplantation for Nonalcoholic Fatty Liver Disease
- ClinicalTrials.gov ID
- NCT03648086
- Acronym / sponsor ID
- NAFLD / 2017005
- Conditions
- Non-alcoholic Fatty Liver Disease
- Keywords
- NAFLD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Zhongshan Hospital Xiamen UniversityUniversity, hospital or other
- Study start
- 14 Nov 2017 (actual)
- Primary completion
- Oct 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 27 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- an open label, parallel study
| Arm | Type | Receives |
|---|---|---|
| IMT | Experimental | Other: intestinal microbiota transplantation30 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. |
| control | No intervention | –30 non-alcoholic fatty liver disease(NAFLD) patients without any treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| intestinal microbiota transplantationAlso: IMTParticipants in Exprerimental group take 6 times IMT with 2-week intervals | Other | IMT |
Primary outcome
The change of CT ratio of liver/spleen
Time frame: 3 months, 6months
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 secondary outcomes
biochemical indicators
Time frame: 3 months, 6months
Fibroscan E value
Time frame: 3 months, 6 months
Changes of gut microbiota
Time frame: 3 months, 6months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing intestinal microbiota transplantation in people with Non-alcoholic Fatty Liver Disease, run by Zhongshan Hospital Xiamen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yang Song (18559666260, tcsongyang@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of CT ratio of liver/spleen (time frame: 3 months, 6months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Aug 2018.