Gut Microbiome in People Living With HIV and HBV

NCT06130137 | Not Yet Recruiting

• 1 other identifier: HIVHBVgutmicrobiome
• Study Type: observational
• Target: 200
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Human Immunodeficiency Virus; Chronic Hepatitis b; Gut Microbiome

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

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

  2 years

Study Arms (2)

HIV

Patients with HIV infection

HBV

Patients with HBV infection

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with chronic viral diseases will be evaluated.

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kangbuk Samsung Hospital: lead
• Kyunghee University Medical Center: collaborator
• Hanyang University: collaborator

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome; Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Eunjeong Joo, M.D., Ph.D

  Kangbuk Samsung Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bomi Kim, M.D.

CONTACT

82-10-8797-7558; springi02@naver.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D, Ph.D

Study Record Dates

• First Submitted: November 8, 2023
• First Posted: November 14, 2023
• Study Start: November 27, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2027
• Last Updated: November 14, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share