Gut Microbiome in People Living With HI… | Clinical Trial

Key information

Conditions

Human Immunodeficiency Virus Acquired Immunodeficiency Syndrome Blood-Borne Infections Chronic Disease Chronic Hepatitis B Communicable Diseases DNA Virus Infections Digestive System Diseases Disease Attributes Genital Diseases Gut Microbiome HIV Infections Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis B, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Immune System Diseases Immunologic Deficiency Syndromes Infections Lentivirus Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Retroviridae Infections Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Slow Virus Diseases Urogenital Diseases Virus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Collect clinical information data and stool from HIV and HBV patients

Time frame: 2 years

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.

Secondary outcomes

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

Time frame: 2 years

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.

Study contacts

Contact information is provided by the study sponsor or research team.

Bomi Kim, M.D.

CONTACT

[email protected]

82-10-8797-7558

Sponsors and collaborators

Lead sponsor

Kangbuk Samsung Hospital

Other

Collaborators

Hanyang University
Kyunghee University Medical Center

Registry information

Official study title

Genome-based Multiomics Analysis on Gut Microbiome in People Living With HIV and HBV

Important dates

Study start: 2023
Primary completion: 2025
Study completion: 2027
First posted: Nov 14, 2023
Registry last updated: Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed