Alterations of Gut Microbiota and Metabolites in ALD Patients
1 other identifier
observational
200
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2022
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2022
CompletedFirst Submitted
Initial submission to the registry
July 2, 2022
CompletedFirst Posted
Study publicly available on registry
July 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2024
CompletedAugust 29, 2023
August 1, 2023
2 years
July 2, 2022
August 28, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
The alterations of gut microbiota in different groups
The alterations will be detected by genome sequencing
When subjects are enrolled
The alterations of gut metabolites in different group
The alterations will be detected by metabolomics
When subjects are enrolled
Study Arms (3)
Alcohol-associated liver disease
drinking, had fatty liver, hepatitis, or hepatic cirrhosis
Purely drinking
drinking, but had no fatty liver and hepatitis.
Healthy control
no drinking and no liver diseases.
Interventions
Collect stool and blood samples from patients
Eligibility Criteria
Patients and healthy control will be recruited mainly from the outpatient or inpatient departments of Wuhan Union Hospital.
You may qualify if:
- \. The group of ALD:
- aged \>18 years;
- patients who meet the diagnostic criteria of ALD in Chinese Guideline for the Prevention and Management of Alcoholic Liver Disease (2018 Update);
- history of chronic heavy alcohol consumption;
- with relatively complete clinical data and good compliance.
- \. The group of purely drinking:
- aged \>18 years;
- history of chronic alcohol consumption;
- no evidence of fatty liver, hepatitis or liver injury.
- \. The group of healthy control:
- aged \>18 years;
- without history of alcohol consumption;
- no evidence of fatty liver, hepatitis or liver injury.
You may not qualify if:
- with hepatocellular carcinoma or hepatic metastases;
- 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);
- 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;
- combined with severe organic lesions of other organs;
- pregnant and lactating women.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430022, China
Related Publications (5)
Chu H, Duan Y, Lang S, Jiang L, Wang Y, Llorente C, Liu J, Mogavero S, Bosques-Padilla F, Abraldes JG, Vargas V, Tu XM, Yang L, Hou X, Hube B, Starkel P, Schnabl B. The Candida albicans exotoxin candidalysin promotes alcohol-associated liver disease. J Hepatol. 2020 Mar;72(3):391-400. doi: 10.1016/j.jhep.2019.09.029. Epub 2019 Oct 10.
PMID: 31606552RESULTDuan Y, Llorente C, Lang S, Brandl K, Chu H, Jiang L, White RC, Clarke TH, Nguyen K, Torralba M, Shao Y, Liu J, Hernandez-Morales A, Lessor L, Rahman IR, Miyamoto Y, Ly M, Gao B, Sun W, Kiesel R, Hutmacher F, Lee S, Ventura-Cots M, Bosques-Padilla F, Verna EC, Abraldes JG, Brown RS Jr, Vargas V, Altamirano J, Caballeria J, Shawcross DL, Ho SB, Louvet A, Lucey MR, Mathurin P, Garcia-Tsao G, Bataller R, Tu XM, Eckmann L, van der Donk WA, Young R, Lawley TD, Starkel P, Pride D, Fouts DE, Schnabl B. Bacteriophage targeting of gut bacterium attenuates alcoholic liver disease. Nature. 2019 Nov;575(7783):505-511. doi: 10.1038/s41586-019-1742-x. Epub 2019 Nov 13.
PMID: 31723265RESULTChu H, Duan Y, Yang L, Schnabl B. Small metabolites, possible big changes: a microbiota-centered view of non-alcoholic fatty liver disease. Gut. 2019 Feb;68(2):359-370. doi: 10.1136/gutjnl-2018-316307. Epub 2018 Aug 31.
PMID: 30171065RESULTJiang L, Chu H, Gao B, Lang S, Wang Y, Duan Y, Schnabl B. Transcriptomic Profiling Identifies Novel Hepatic and Intestinal Genes Following Chronic Plus Binge Ethanol Feeding in Mice. Dig Dis Sci. 2020 Dec;65(12):3592-3604. doi: 10.1007/s10620-020-06461-6. Epub 2020 Jul 15.
PMID: 32671585RESULTChu H, Williams B, Schnabl B. Gut microbiota, fatty liver disease, and hepatocellular carcinoma. Liver Res. 2018 Mar;2(1):43-51. doi: 10.1016/j.livres.2017.11.005. Epub 2018 Feb 21.
PMID: 30416839RESULT
Related Links
Biospecimen
Retain patient blood and stool and extract DNA for identification of gut microbiota.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Huikuan Chu, M.D.
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate chief physician
Study Record Dates
First Submitted
July 2, 2022
First Posted
July 7, 2022
Study Start
June 1, 2022
Primary Completion
June 1, 2024
Study Completion
December 1, 2024
Last Updated
August 29, 2023
Record last verified: 2023-08