Gut Microbiome in People Living With HIV and HBV

Not yet recruiting

• Conditions: Human Immunodeficiency Virus; Gut Microbiome; Chronic Hepatitis b

• Registration Number: NCT06130137
• Lead Sponsor: Kangbuk Samsung Hospital

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 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 Timeline

• Status Verified: 2023-11
• Study First Submitted: 2023-11-08
• Study First Submitted QC: 2023-11-08
• Last Update Submitted: 2023-11-08
• Study First Posted: 2023-11-14
• Last Update Posted: 2023-11-14
• Study Start: 2023-11-27
• Primary Completion: 2025-12-31
• Study Completion: 2027-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Collect clinical information data and stool from HIV and HBV patients	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 Outcome Measures

Name	Time	Method
Shotgun metagenomic sequencing will be done with stool collected from HIV and HBV patients	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.