Examining gut microbiota changes in patients with drug-induced liver injury
Alterations of Gut Microbiota and Serum Biochemical Markers in Asian Patients With Drug-induced Liver Injury
This study is trying to see how changes in gut bacteria might be linked to liver problems caused by medications in people who have drug-induced liver injury.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 90 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Wuhan Union Hospital, China Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT05465642 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between gut microbiota alterations and serum biochemical markers in patients suffering from drug-induced liver injury (DILI). It aims to collect demographic data, clinical labs, and biological samples from participants to analyze the gut microbiota through 16S rRNA amplicon sequencing and serum metabolomics detection. By comparing DILI patients with healthy controls, the study seeks to uncover the mechanisms by which gut microbiota may influence the development of DILI, potentially leading to new therapeutic targets.
Who should consider this trial
Good fit: Ideal candidates include adults over 18 years old who have been diagnosed with drug-induced liver injury and have a history of taking hepatotoxic drugs.
Not a fit: Patients with hepatocellular carcinoma, infectious liver diseases, or other significant liver conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the role of gut microbiota in DILI, leading to improved diagnostic and therapeutic strategies for affected patients.
How similar studies have performed: While the relationship between gut microbiota and liver health is being explored, this specific approach to studying DILI through microbiota alterations is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. The group of DILI: 1. aged \>18 years; 2. patients who meet the diagnostic criteria of DILI in Guidelines for Diagnosis and Treatment of Drug-induced Liver Injury; 3. history of taking hepatotoxic drugs; 4. with relatively complete clinical data and good compliance. 2. The group of healthy control: 1. aged \>18 years; 2. no history of liver disease and other diseases. Exclusion Criteria: 1. with hepatocellular carcinoma (HCC) 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, 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; 4. combined with severe organic lesions of other organs; 5. pregnant and lactating women.
Where this trial is running
Wuhan, Hubei
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Huikuan Chu, M.D.
- Email: 2012xh0827@hust.edu.cn
- Phone: +8613554105386
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.