Gut Microbiome in People Living With HIV and HBV

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Hepatitis b; Human Immunodeficiency Virus; Gut Microbiome

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Bomi Kim, M.D.; Phone Number: 82-10-8797-7558; Email: springi02@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Individuals with chronic viral diseases will be evaluated.

Description

Inclusion Criteria:

1. HIV patients

   • Inidividuals over 19 years old
   • HIV patients on antiretroviral therapy (ART)

2. HBV patients

   • Individuals over 19 years old
   • Chronic hepatitis B patients with either chronic hepatitis, liver cirrhosis or hepatocellular carcinoma

Exclusion Criteria:

1. Patients with indeterminate colitis
2. Individuals who have used antibiotics or steroids within 24 hours of the microbiome sample collection (excluding antiviral treatments for hepatitis B and HIV)
3. Individuals who have used vaginal or external medications, including antifungal agents, within 24 hours of microbiome sample collection
4. Those with acute illnesses, with or without fever, of moderate or severe severity; however, sampling may be postponed until the subject recovers.
5. Individuals with gastrointestinal disorders that may impact microbiome analysis and are currently medically uncontrolled or under treatment for the respective condition
6. Individuals with a positive result in a urine pregnancy test, pregnant, or breastfeeding at the time of microbiome sample collection
7. Individuals for whom medical opinions suspect that they may have an impact on the sample collection at the time of microbiome collection.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
HIV; Patients with HIV infection
HBV; Patients with HBV infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	2 years

Collaborators and Investigators

• Sponsor: Kangbuk Samsung Hospital
• Collaborators: Hanyang University; Kyunghee University Medical Center
• Investigators: Principal Investigator: Eunjeong Joo, M.D., Ph.D, Kangbuk Samsung Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): November 27, 2023
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: November 8, 2023
• First Submitted That Met QC Criteria: November 8, 2023
• First Posted (Estimated): November 14, 2023

Study Record Updates

• Last Update Posted (Estimated): November 14, 2023
• Last Update Submitted That Met QC Criteria: November 8, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; Immunologic Deficiency Syndromes; Immune System Diseases; Disease Attributes; Liver Diseases; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Hepatitis, Chronic; Slow Virus Diseases; Hepatitis; Chronic Disease; Urogenital Diseases; Genital Diseases; HIV Infections; Hepatitis B; Hepatitis B, Chronic; Acquired Immunodeficiency Syndrome
• Other Study ID Numbers: HIVHBVgutmicrobiome

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No