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NCT04353778 · ClinicalTrials.gov registry record · Phase 1
Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV
A Phase 1 study of HIV and Non-HIV, sponsored by Icahn School of Medicine at Mount Sinai.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 207
- Enrollment target
- 1
- Study location
NCT04353778 is a Phase 1 study of HIV and Non-HIV that is actively recruiting participants, run by Icahn School of Medicine at Mount Sinai. The registered enrollment target is 207 participants, below the 439-participant average among 303 other HIV trials with a reported enrollment target (53% lower). The trial reports 1 study location across 1 state.
The verdict
NCT04353778, a Phase 1 study of HIV and Non-HIV, is actively recruiting participants, sponsored by Icahn School of Medicine at Mount Sinai.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 207 participants
- Enrollment target
- 1
- Study location
Study Summary
The study team's prior research has shown that dysfunction of a specific nerve, called the vagus nerve, is associated with small intestinal bacterial overgrowth (SIBO), and that SIBO is associated with signs of inflammation in the blood of people living with HIV (PLWH). This research will explore pathways linking vagal dysfunction to inflammation in HIV, focusing on the gastrointestinal tract, and study whether a medication called pyridostigmine and stimulation of the vagus nerve are beneficial therapies.
Conditions Studied
Interventions
- DRUG Placebos
- DRUG Pyridostigmine
- PROCEDURE non-invasive vagal nerve stimulation
Study Locations (1)
New York
- Icahn School of Medicine at Mount Sinai - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 207 participants |
| Start Date | 2020-08-03 |
| Est. Completion | 2026-09-16 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04353778
The ClinicalTrials.gov registry entry for NCT04353778 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 207 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 439-participant average among 303 other HIV trials with a reported enrollment target (53% lower). The listed sponsor is Icahn School of Medicine at Mount Sinai, which has 708 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with HIV appearing as the primary indexed condition, and to 3 interventions - of which Placebos is the first listed.
NCT04353778 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT04353778 about?
NCT04353778 is a clinical study titled "Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV". The study team's prior research has shown that dysfunction of a specific nerve, called the vagus nerve, is associated with small intestinal bacterial overgrowth (SIBO), and that SIBO is associated with signs of inflammation in the blood of people living with HIV (PLWH). This research will explore pa...
What is the current status of trial NCT04353778?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 207 participants. The study started on 2020-08-03. Estimated completion is 2026-09-16.
What conditions does trial NCT04353778 study?
This clinical trial studies the following conditions: HIV, Non-HIV, Vagus Nerve Dysfunction.
What interventions are being tested in trial NCT04353778?
The interventions under investigation include: Placebos (DRUG), Pyridostigmine (DRUG), non-invasive vagal nerve stimulation (PROCEDURE).
Who is sponsoring clinical trial NCT04353778?
This trial is sponsored by Icahn School of Medicine at Mount Sinai, which has 708 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04353778 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.