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RECRUITING
NCT04353778
PHASE1/PHASE2

Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

207

Start Date

2020-08-03

Completion Date

2026-09-16

Last Updated

2026-02-19

Healthy Volunteers

Yes

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

Locations (1)

Icahn School of Medicine at Mount Sinai

New York, New York, United States