Gut Microbiome in People Living With HIV and HBV
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Human Immunodeficiency Virus, Chronic Hepatitis b, Gut Microbiome. Basic parameters: from 19 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Genome-based Multiomics Analysis on Gut Microbiome in People Living With HIV and HBV
Overview
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 gut microbiota in individuals with chronic HIV infection and chronic hepatitis B patients. The objective is to identify specific gut bacterial strains and metabolic pathways linked to the metabolic disorders commonly observed in HIV patients.
Primary outcome measures
- Collect clinical information data and stool from HIV and HBV patients [Time frame: 2 years]
Secondary outcome measures (1)
- Shotgun metagenomic sequencing will be done with stool collected from HIV and HBV patients [Time frame: 2 years]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06130137 · HIVHBVgutmicrobiome