Gut Microbiome in People Living With HIV and HBV

ConditionsHuman Immunodeficiency Virus Chronic Hepatitis b Gut Microbiome

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age19+

SponsorKangbuk Samsung Hospital

About this trial

Building a Microbiome Data Platform and Conducting Clinical Evidence Research in Individuals Infected with the Human Immunodeficiency Virus (HIV) and Hepatitis B virus.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

HIV patients

Inidividuals over 19 years old

HIV patients on antiretroviral therapy (ART)

HBV patients

Disqualifiers

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.

Trial population

Individuals with chronic viral diseases will be evaluated.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

200 Participants

are grouped into 2 trial groups

Group A: HIV

Group B: HBV

Trial outcomes

Primary outcomes

Collect clinical information data and stool from HIV and HBV patients

Clinical information data will be collected from both HIV and HBV infected patients. Biosamples collected from these individuals will be used to establish a multi-omics analysis platform, including the examination of the intestinal microbiome. With this platform, comparative clinical studies will be conducted to uncover the disease's pathophysiology and identify potential biomarkers related to metabolic diseases.

Time frame

2 years

Secondary outcomes

Shotgun metagenomic sequencing will be done with stool collected from HIV and HBV patients

Diversity analysis: Alpha and beta diversity analyses are conducted to determine differences in the composition of gut microbiota between healthy individuals and patients. Important feature selection: Differential abundance analysis (e.g., using methods like LEfSe or ANCOM) or machine learning (e.g., random forest, support vector machine) is employed to identify microbiota. Functional profile prediction: In cases where metagenomic analysis is not feasible, the PICRUSt2 program is utilized to predict and analyze functional profiles based on the phylogeny of the microbiota present in healthy individuals and patients.

Time frame

2 years

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kangbuk Samsung Hospital

Lead sponsor

Kyunghee University Medical Center

Collaborator

Hanyang University