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NCT06130137Not yet recruiting

Gut Microbiome in People Living With HIV and HBV

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

Source: ClinicalTrials.gov · Last updated 14 Nov 2023 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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

Status (registry)
Not yet recruiting
Study type
Observational
Enrollment
200 (estimated)
First submitted
8 Nov 2023
Start date
27 Nov 2023
Primary completion date
31 Dec 2025
Lead sponsor
Kangbuk Samsung Hospital
Diseases
Hepatitis B, HIV
NCT number
NCT06130137

What you commit to

  • Study type: Observational
  • Planned participants: 200
  • From 27 Nov 2023 to the primary completion date, 31 Dec 2025
  • No sites listed in no country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Individuals who have used vaginal or external medications, including antifungal agents, within 24 hours of microbiome sample collection

Other illness

  • Individuals who have used antibiotics or steroids within 24 hours of the microbiome sample collection (excluding antiviral treatments for hepatitis B and HIV)
  • 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

Other

  • Patients with indeterminate colitis
  • 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.

Who the study is looking for

  • 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

Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

This page is information, not medical advice. Discuss any trial with your doctor.