Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT04353778
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • HIV
  • Non-HIV
  • Vagus Nerve Dysfunction

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Pyridostigmine — DRUG
    Eight weeks of low-dose pyridostigmine
  • Placebos — DRUG
    matching placebo x 8 weeks
  • non-invasive vagal nerve stimulation — PROCEDURE
    stimulation of the vagus nerve

Study Details

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.

Key Dates

Start date
Aug 3, 2020
Status verified
Feb 2026
Primary completion
Sep 16, 2026
Completion
Sep 16, 2026

Study Design

Enrollment
207 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • No Intervention: PLWH
    People living with HIV (HIV)
  • No Intervention: Healthy Controls
    Healthy controls who do not have HIV
  • Active Comparator: Pyridostigmine
    PLWH on pyridostigmine 30mg PO TID
  • Placebo Comparator: Placebo
    PLWH on placebo
  • Other: nVNS
    PLWH to undergo non-invasive vagal nerve stimulation

Primary Outcome Measure

Small bowel transit time (SBTT) [ Time Frame: 8 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Alexandra Nmashie, MD
[email protected]
212-241-3193
Mary Catherine George, MM,PhD
[email protected]
212-241-0784
Jessica Robinson- Papp, MD (PRINCIPAL_INVESTIGATOR)

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By condition
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By specialty
Infectious disease
By research site
Icahn School of Medicine at Mount Sinai· New York, NY

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