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Not yet recruitingNCT06130137Updated Nov 14, 2023

Gut Microbiome in People Living With HIV and HBV

An observational study in Human Immunodeficiency Virus, Chronic Hepatitis b and Gut Microbiome, sponsored by Kangbuk Samsung Hospital. Not yet recruiting. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2023-11-14.

Sponsored by Kangbuk Samsung Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as not yet recruiting.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Ages
19 Years and older
Sex
All
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Study summary

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

Read the 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.

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Conditions studied

  • Human Immunodeficiency Virus
  • Chronic Hepatitis b
  • Gut Microbiome
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In context

Acquired Immunodeficiency Syndrome

2,099 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 273 are open to participants now.

This study's planned enrollment of 200 is below the median of 239 across 367 observational studies indexed under Acquired Immunodeficiency Syndrome.

Browse Acquired Immunodeficiency Syndrome studies →

Lead sponsor

Kangbuk Samsung Hospital is the lead sponsor of 63 studies on the registry; 9 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Individuals with chronic viral diseases will be evaluated.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (estimated)
Patient registry
No

Groups and cohorts

  • HIV

    Patients with HIV infection

  • HBV

    Patients with HBV infection

06

What researchers measure

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.

    Time frame: 2 years

Secondary outcomes

  1. 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.

    Time frame: 2 years

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 14, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06130137
Lead sponsor
Kangbuk Samsung Hospital
Collaborators
Kyunghee University Medical Center, Hanyang University
Responsible party
Eun-Jeong Joo (M.D, Ph.D, Kangbuk Samsung Hospital) — Principal investigator
First posted
Nov 14, 2023
Start date
Nov 27, 2023 (estimated)
Primary completion
Dec 31, 2025 (estimated)
Completion
Dec 31, 2027 (estimated)
Last update
Nov 14, 2023

Study contacts

Bomi Kim, M.D.
Contact
springi02@naver.com
82-10-8797-7558
Eunjeong Joo, M.D., Ph.D
principal investigator · Kangbuk Samsung Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.

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