Alterations of Gut Microbiota and Serum Biochemical Markers in DILI Patients

NCT05465642 | Unknown

• 1 other identifier: UHCT22354
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Drug-induced liver injury is a leading cause of acute liver failure worldwide and one of the least understood areas in hepatology research. Increasing evidence has shown that drug-induced liver injury is associated with gut microbiota.

Conditions

Drug-induced Liver Injury; Gut Microbiota; Biochemical Markers

Keywords

DILI; gut microbiota; serum biochemical markers

Outcome Measures

Primary Outcomes (4)

• The changes of gut microbiota in the levels of phylum, genus, and species in two groups

  The changes will be detected by genome sequencing

  2 years

• The different levels of serum aspartate transaminase/alanine transaminase (AST/ALT) in two groups

  The changes will be detected by biochemical analyzers

  2 years

• The different levels of proinflammatory cytokines in two groups

  The changes will be determined by ELISA kits

  2 years

• The changes of lncRNA and miRNA in two groups

  The changes will be measured by quantitative polymerase chain reaction (qPCR)

  2 years

Study Arms (2)

Drug-induced liver injury

history of taking hepatotoxic drugs, liver injury.

Other: Collect stool and blood samples from patients

Healthy control

no liver disease or other disease

Other: Collect stool and blood samples from patients

Interventions

Collect stool and blood samples from patients OTHER

Collect stool and blood samples from patients

Drug-induced liver injury; Healthy control

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. The group of DILI:
• aged \>18 years;
• patients who meet the diagnostic criteria of DILI in Guidelines for Diagnosis and Treatment of Drug-induced Liver Injury;
• history of taking hepatotoxic drugs;
• with relatively complete clinical data and good compliance.
• \. The group of healthy control:
• aged \>18 years;
• no history of liver disease and other diseases.

You may not qualify if:

• with hepatocellular carcinoma (HCC) 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, alcoholic liver disease, autoimmune liver disease, immunoglobulin G4-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.

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (4)

• Hartmann P, Chu H, Duan Y, Schnabl B. Gut microbiota in liver disease: too much is harmful, nothing at all is not helpful either. Am J Physiol Gastrointest Liver Physiol. 2019 May 1;316(5):G563-G573. doi: 10.1152/ajpgi.00370.2018. Epub 2019 Feb 15.

  PMID: 30767680 RESULT

• Wu G, Win S, Than TA, Chen P, Kaplowitz N. Gut Microbiota and Liver Injury (I)-Acute Liver Injury. Adv Exp Med Biol. 2020;1238:23-37. doi: 10.1007/978-981-15-2385-4_3.

  PMID: 32323178 RESULT

• Gong S, Lan T, Zeng L, Luo H, Yang X, Li N, Chen X, Liu Z, Li R, Win S, Liu S, Zhou H, Schnabl B, Jiang Y, Kaplowitz N, Chen P. Gut microbiota mediates diurnal variation of acetaminophen induced acute liver injury in mice. J Hepatol. 2018 Jul;69(1):51-59. doi: 10.1016/j.jhep.2018.02.024. Epub 2018 Mar 8.

  PMID: 29524531 RESULT

• Schneider KM, Elfers C, Ghallab A, Schneider CV, Galvez EJC, Mohs A, Gui W, Candels LS, Wirtz TH, Zuehlke S, Spiteller M, Myllys M, Roulet A, Ouzerdine A, Lelouvier B, Kilic K, Liao L, Nier A, Latz E, Bergheim I, Thaiss CA, Hengstler JG, Strowig T, Trautwein C. Intestinal Dysbiosis Amplifies Acetaminophen-Induced Acute Liver Injury. Cell Mol Gastroenterol Hepatol. 2021;11(4):909-933. doi: 10.1016/j.jcmgh.2020.11.002. Epub 2020 Nov 12.

  PMID: 33189892 RESULT

Related Links

• This web provides information of Human Subjects Protection in this study

Biospecimen

Retention: SAMPLES WITH DNA

Retain patient blood and stool and extract DNA for identification of gut microbiota.

MeSH Terms

Conditions

Chemical and Drug Induced Liver Injury

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Study Officials

• Huikuan Chu, M.D.

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, wuhan

  STUDY DIRECTOR

Central Study Contacts

Huikuan Chu, M.D.

CONTACT

+8613554105386; 2012xh0827@hust.edu.cn

Wenkang Gao, Dr.

CONTACT

+8618838022896; gwkmed@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate chief physician

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 20, 2022
• Study Start: July 4, 2022
• Primary Completion: July 1, 2024
• Study Completion: December 1, 2024
• Last Updated: August 31, 2023

Record last verified: 2023-08

Locations

CN (1)