Actively Recruiting
Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-02-19
207
Participants Needed
1
Research Sites
319 weeks
Total Duration
On this page
Sponsors
I
Icahn School of Medicine at Mount Sinai
Lead Sponsor
N
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
Official Title
Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Documented HIV-1 infection
- Stable combination antiretroviral therapy for at least 3 months
- HIV-1 viral load less than 100 copies/ml within the last 3 months
- No diagnosis causing autonomic or gastrointestinal dysfunction other than HIV
- Willing to avoid nicotine use for 24 hours before all testing
- No contraindications to autonomic testing
- No use of medications with significant autonomic or gastrointestinal effects
- Negative urine test for stimulants, opiates/opioids, and pregnancy test if applicable
You will not qualify if you...
- Difficulty swallowing food or pills
- Known or suspected obstructive gastrointestinal disease
- Gastrointestinal surgery within the last 3 months
- Conditions like Crohn's disease or diverticulitis
- Presence of electromechanical medical devices such as pacemakers or infusion pumps
- Contraindications to pyridostigmine or use of pyridostigmine within the past 6 months
- History of brain aneurysm, brain tumor, abnormal neck anatomy, implants or metal hardware near stimulation site
- Exposure to vagal nerve stimulation within the past 6 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Actively Recruiting
Research Team
N
Niyati Neupane
CONTACT
M
Mary Catherine George, MM, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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