Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV

Recruiting now · Phase 1/Phase 2 · Has a placebo group

Conditions studied: HIV, Non-HIV, Vagus Nerve Dysfunction

In brief

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 facts

Study ID

NCT04353778

Run by

Icahn School of Medicine at Mount Sinai

People needed

207

Starts

2020-08-03

Expected to finish

2026-09-16

Last updated by the study team

2026-02-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Greater than or equal to18 years old (18 to 64 Years, 65 Years and Over)
• Documentation of HIV-1 infection
• Stable CART for greater or equal to 3 months
• HIV-1 viral load <100 copies/ml (within 3m)
• No diagnosis known to cause autonomic or GI dysfunction other than HIV (e.g. Parkinson's disease, diabetes, peptic ulcer disease, infectious diarrhea)
• Willing to refrain from nicotine use for 24h prior to all testing
• No contraindication to autonomic testing (e.g. uncontrolled glaucoma, heart rate not under sinus control)
• No medications with significant autonomic or GI effects (e.g. sympathomimetics, prokinetics, anti-diarrheals, antibiotics)
• Urine test negative for stimulants and opiates/opioids and pregnancy test (if applicable)

You may not qualify if…

• Dysphagia to food or pills
• Known or suspected obstructive disease of the GI tract (e.g. bezoar, strictures, fistulae, physiologic GI obstruction)
• GI surgery within 3m, Crohn's disease, diverticulitis, any electromechanical medical device (e.g. pacemaker, infusion pump).
• Contraindication to pyridostigmine (e.g. mechanical intestinal or urinary obstruction, hypersensitivity to pyridostigmine, cardiac arrhythmias, asthma, chronic obstructive pulmonary disease); use of pyridostigmine within the past 6m.
• History of intracranial aneurysm/hemorrhage, brain tumor, abnormal neck anatomy, or implants or metal hardware near site of stimulation; exposure to VNS within the past 6m.

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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