NCT04353778 · Icahn School of Medicine at Mount Sinai
Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV
(EVA)
What this study 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).
View original scientific description
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.
Interventions
DRUG
Pyridostigmine
Eight weeks of low-dose pyridostigmine
DRUG
Placebos
matching placebo x 8 weeks
PROCEDURE
non-invasive vagal nerve stimulation
stimulation of the vagus nerve
Primary outcome measures
Small bowel transit time (SBTT)
Time frame: 8 weeks
Small bowel transit time (SBTT) measured by wireless motility capsule (wmc, smartpill)
Gastric pH measurement
Time frame: 8 weeks
Gastric pH measurement measured by wireless motility capsule (wmc, smartpill)
Hydrogen/methane breath testing (hbt)
Time frame: 8 weeks
hydrogen/methane breath testing (hbt) to measure small intestinal bacterial overgrowth
IL6 measurement [Time Frame: 5 years]
Time frame: 8 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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)
Exclusion criteria
- 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
- New York, New York
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 19, 2026 · Source of record for eligibility and locations