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Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV

NCT04353778 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 207

Last updated 2026-02-19

No results posted yet for this study

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.

Conditions

  • HIV
  • Non-HIV
  • Vagus Nerve Dysfunction

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

Sponsors & Collaborators

Principal Investigators

  • Jessica Robinson-Papp, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2020-08-03
Primary Completion
2026-09-16
Completion
2026-09-16
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04353778 on ClinicalTrials.gov