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NCT06113003 · ClinicalTrials.gov registry record · Early Phase 1
The Gut, Liver And Metabolome in Human Immunodeficiency Virus and Non Alcoholic Fatty Liver Disease
A Early Phase 1 study of HIV and Non-alcoholic Fatty Liver Disease, sponsored by Vanderbilt University Medical Center.
- Recruiting
- Registry status
- Early Phase 1
- Development phase
- 63
- Enrollment target
- 1
- Study location
NCT06113003 is a Early Phase 1 study of HIV and Non-alcoholic Fatty Liver Disease that is actively recruiting participants, run by Vanderbilt University Medical Center. The registered enrollment target is 63 participants, below the 440-participant average among 303 other HIV trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06113003, a Early Phase 1 study of HIV and Non-alcoholic Fatty Liver Disease, is actively recruiting participants, sponsored by Vanderbilt University Medical Center.
- RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 63 participants
- Enrollment target
- 1
- Study location
Study Summary
Persons with human immunodeficiency virus (HIV) have higher risk of developing fatty liver disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are not known. Changes in the intestinal microbiome may contribute to the development of NAFLD in persons with HIV (PWH) through impairment of barrier function of the intestinal wall and by producing metabolites that are harmful to the liver. This project will test the hypothesis that HIV-related NAFLD is associated with differences in the intestinal microbiome and that supplementation with probiotic and prebiotic fiber will lead to improvements in markers of NAFLD in PWH.
Conditions Studied
Interventions
- DIETARY_SUPPLEMENT Probiotic
- DIETARY_SUPPLEMENT Prebiotic
Study Locations (1)
Tennessee
- Vanderbilt University Medical Center - Nashville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 63 participants |
| Start Date | 2024-04-18 |
| Est. Completion | 2026-03-01 |
| Phase | Early Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06113003
The ClinicalTrials.gov registry entry for NCT06113003 describes a study currently listed as recruiting, categorized as Early Phase 1. The registered enrollment target is 63 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 303 other HIV trials with a reported enrollment target (86% lower). The listed sponsor is Vanderbilt University Medical Center, which has 677 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with HIV appearing as the primary indexed condition, and to 2 interventions - of which Probiotic is the first listed.
NCT06113003 reports 1 study location spanning 1 distinct geographic area - top geographies include Tennessee.
Frequently Asked Questions
What is clinical trial NCT06113003 about?
NCT06113003 is a clinical study titled "The Gut, Liver And Metabolome in Human Immunodeficiency Virus and Non Alcoholic Fatty Liver Disease". Persons with human immunodeficiency virus (HIV) have higher risk of developing fatty liver disease (NAFLD) than HIV-negative persons but the reasons for this discrepancy are not known. Changes in the intestinal microbiome may contribute to the development of NAFLD in persons with HIV (PWH) through i...
What is the current status of trial NCT06113003?
This trial is currently recruiting. It is a Early Phase 1 study. The enrollment target is 63 participants. The study started on 2024-04-18. Estimated completion is 2026-03-01.
What conditions does trial NCT06113003 study?
This clinical trial studies the following conditions: HIV, Non-alcoholic Fatty Liver Disease, Metabolic Associated Steatotic Liver Disease.
What interventions are being tested in trial NCT06113003?
The interventions under investigation include: Probiotic (DIETARY_SUPPLEMENT), Prebiotic (DIETARY_SUPPLEMENT).
Who is sponsoring clinical trial NCT06113003?
This trial is sponsored by Vanderbilt University Medical Center, which has 677 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06113003 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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