Gut Microbiome in People Living With HIV and HBV

NCT ID: NCT06130137

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-11-27

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Human Immunodeficiency Virus Chronic Hepatitis b Gut Microbiome

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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HIV

Patients with HIV infection

No interventions assigned to this group

HBV

Patients with HBV infection

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kyunghee University Medical Center

OTHER

Sponsor Role collaborator

Hanyang University

OTHER

Sponsor Role collaborator

Kangbuk Samsung Hospital

OTHER

Sponsor Role lead

Responsible Party

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Eun-Jeong Joo

M.D, Ph.D

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eunjeong Joo, M.D., Ph.D

Role: PRINCIPAL_INVESTIGATOR

Kangbuk Samsung Hospital

Central Contacts

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Bomi Kim, M.D.

Role: CONTACT

82-10-8797-7558

Other Identifiers

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HIVHBVgutmicrobiome

Identifier Type: -

Identifier Source: org_study_id

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