Alterations of Gut Microbiota and Metabolites in ALD Patients

August 28, 2023 updated by: Huikuan Chu, MD, Wuhan Union Hospital, China

Alterations of Gut Microbiota and Metabolites in Asian Patients With Alcohol-associated Liver Disease

Alcohol-associated liver disease is one of the most prevalent liver diseases worldwide, and the leading cause of liver transplantation in the U.S. Alcohol-related liver disease is associated with changes in the intestinal microbiota and metabolites.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Backgrounds:

Alcohol-associated liver disease (ALD) is a common disease caused by alcohol use disorder (AUD), ranging from asymptomatic liver steatosis to alcohol-associated hepatitis (AH), alcoholic cirrhosis and potentially, hepatocellular carcinoma (HCC). ALD is the most common reason for liver transplantation in the United States. Globally, about 2 million people die from liver disease each year and up to 50% of the death with cirrhosis can be attributed to alcohol consumption. In Europe, it has been estimated that 60%-80% of liver-related deaths can be attributed to alcohol consumption. Currently, the pathogenetic mechanisms have not been fully elucidated, but they might be related to oxidative stress, acetaldehyde-induced toxicity, cytokine and chemokine-induced inflammation. There is no effective therapeutic method for ALD till now except for liver transplantation. Recent studies have reported that gut microbiota has an intimate relationship with ALD, which provides broader insights and opportunities for understanding and treating this disease.

Aims:

We aim to map the alterations of gut microbiota and metabolites in patients with different levels of ALD, and to investigate the effects and mechanisms of key strains and their metabolites on the development of ALD, providing a theoretical basis and potential targets for its treatment.

Methods:

Patients who meet the inclusion criteria will sign informed consent, their demographic data, clinical labs, serum, and feces for shotgun metagenomics will be collected at baseline.

Anticipated Results:

Compared to healthy control group, patients with AH or alcohol-associated hepatic cirrhosis will suffer from microbiota dysbiosis and have more microbes and microbial genes associated with inflammation and fibrosis. Gut microbiota-derived metabolites may exacerbate the severity of ALD. Several microorganisms or metabolites can be used as prognostic markers.

Implications and Future Studies:

Results of altered gut microbiome and metabolites could provide potential targets for manipulating intestinal microbiota to prevent or treat ALD.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Wenkang Gao, Dr.
  • Phone Number: +8618838022896
  • Email: gwkmed@163.com

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients and healthy control will be recruited mainly from the outpatient or inpatient departments of Wuhan Union Hospital.

Description

Inclusion Criteria:

1. The group of ALD:

  1. aged >18 years;
  2. patients who meet the diagnostic criteria of ALD in Chinese Guideline for the Prevention and Management of Alcoholic Liver Disease (2018 Update);
  3. history of chronic heavy alcohol consumption;
  4. with relatively complete clinical data and good compliance.

2. The group of purely drinking:

  1. aged >18 years;
  2. history of chronic alcohol consumption;
  3. no evidence of fatty liver, hepatitis or liver injury.

3. The group of healthy control:

  1. aged >18 years;
  2. without history of alcohol consumption;
  3. no evidence of fatty liver, hepatitis or liver injury.

Exclusion Criteria:

  1. with hepatocellular carcinoma or hepatic metastases;
  2. combined with infectious liver diseases, such as hepatitis A virus, hepatitis B virus, hepatitis C virus, hepatitis D virus, hepatitis E virus and human immunodeficiency virus (HIV);
  3. combined with non-infectious liver diseases, such as non-alcoholic fatty liver disease, drug-induced hepatitis, autoimmune liver disease, Immunoglobulin G subclass 4-related liver disease, Wilson's disease, alpha 1-antitrypsin deficiency, Budd-Chiari syndrome, and other congenital liver diseases;
  4. combined with severe organic lesions of other organs;
  5. pregnant and lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Alcohol-associated liver disease
drinking, had fatty liver, hepatitis, or hepatic cirrhosis
Other: Collect stool and blood samples from patients
Collect stool and blood samples from patients
Purely drinking
drinking, but had no fatty liver and hepatitis.
Other: Collect stool and blood samples from patients
Collect stool and blood samples from patients
Healthy control
no drinking and no liver diseases.
Other: Collect stool and blood samples from patients
Collect stool and blood samples from patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The alterations of gut microbiota in different groups
Time Frame: When subjects are enrolled
The alterations will be detected by genome sequencing
When subjects are enrolled
The alterations of gut metabolites in different group
Time Frame: When subjects are enrolled
The alterations will be detected by metabolomics
When subjects are enrolled

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Investigators

  • Study Director: Huikuan Chu, M.D., Wuhan Union Hospital, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 2, 2022

First Submitted That Met QC Criteria

July 2, 2022

First Posted (Actual)

July 7, 2022

Study Record Updates

Last Update Posted (Actual)

August 29, 2023

Last Update Submitted That Met QC Criteria

August 28, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHCT22032

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gut Microbiota

Clinical Trials on Collect stool and blood samples from patients

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe