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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: Recruiting Phase 1 study of HIV and Non-HIV, sponsored by Icahn School of Medicine at Mount Sinai.
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. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Small bowel transit time (SBTT) measured by wireless motility capsule (wmc, smartpill)
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 |
What NCT04353778 shows while recruiting
NCT04353778 is an interventional study that assigns participants to a tested intervention. The registered 207 participants enrollment target is mid-sized for trials with a published cap, below the 439-participant average among 303 other HIV trials with a reported enrollment target (53% lower).
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 a single indexed study location in 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.
Learn More About Clinical Trials
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Where NCT04353778's enrollment target sits among peer trials
207 101st of 303 higher than 203 of 303 other HIV trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HIV trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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