RecruitingPhase 1Phase 2NCT04353778

Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV


Sponsor

Icahn School of Medicine at Mount Sinai

Enrollment

207 participants

Start Date

Aug 3, 2020

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating how HIV affects the vagus nerve — the nerve that connects the brain to the gut and helps regulate digestion and inflammation. Researchers want to understand whether damage to this nerve (called vagal dysfunction) contributes to digestive problems and immune system inflammation in people with HIV, even those whose virus is well controlled. **You may be eligible if:** - You are 18 years or older - You have documented HIV-1 infection - You have been on stable HIV treatment (ART) for at least 3 months - Your HIV viral load is below 100 copies/mL (well controlled) - You do not have other conditions known to affect the nervous system or digestive system (such as Parkinson's disease, diabetes, or active infections causing diarrhea) - You are willing to avoid nicotine for 24 hours before each test **You may NOT be eligible if:** - You have uncontrolled glaucoma or an irregular heartbeat not controlled by the heart's natural rhythm - You are taking medications that significantly affect the nervous system or digestive system - Your urine test is positive for stimulants or opioids - You are pregnant Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGPyridostigmine

Eight weeks of low-dose pyridostigmine

DRUGPlacebos

matching placebo x 8 weeks

PROCEDUREnon-invasive vagal nerve stimulation

stimulation of the vagus nerve


Locations(1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04353778


Related Trials