Status:
NOT_YET_RECRUITING
Gut Microbiome in People Living With HIV and HBV
Lead Sponsor:
Kangbuk Samsung Hospital
Collaborating Sponsors:
Kyunghee University Medical Center
Hanyang University
Conditions:
Human Immunodeficiency Virus
Chronic Hepatitis b
Eligibility:
All Genders
19+ years
Brief Summary
Building a Microbiome Data Platform and Conducting Clinical Evidence Research in Individuals Infected with the Human Immunodeficiency Virus (HIV) and Hepatitis B virus.
Detailed Description
Chronic HIV infection, which often results in metabolic disorders, leads to shifts in the gut microbiota, contributing to immune activation and chronic inflammation. This study seeks to compare the gu...
Eligibility Criteria
Inclusion
- HIV patients
- Inidividuals over 19 years old
- HIV patients on antiretroviral therapy (ART)
- HBV patients
- Individuals over 19 years old
- Chronic hepatitis B patients with either chronic hepatitis, liver cirrhosis or hepatocellular carcinoma
Exclusion
- Patients with indeterminate colitis
- Individuals who have used antibiotics or steroids within 24 hours of the microbiome sample collection (excluding antiviral treatments for hepatitis B and HIV)
- Individuals who have used vaginal or external medications, including antifungal agents, within 24 hours of microbiome sample collection
- Those with acute illnesses, with or without fever, of moderate or severe severity; however, sampling may be postponed until the subject recovers.
- Individuals with gastrointestinal disorders that may impact microbiome analysis and are currently medically uncontrolled or under treatment for the respective condition
- Individuals with a positive result in a urine pregnancy test, pregnant, or breastfeeding at the time of microbiome sample collection
- Individuals for whom medical opinions suspect that they may have an impact on the sample collection at the time of microbiome collection.
Key Trial Info
Start Date :
November 27 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06130137
Start Date
November 27 2023
End Date
December 31 2027
Last Update
November 14 2023
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