Status:
ENROLLING_BY_INVITATION
Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Collaborating Sponsors:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
HIV
Non-HIV
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 wit...
Detailed Description
Objectives Aim 1: To elucidate mechanisms linking VD, SIBO and chronic inflammation in PLWH. PLWH (N=150) will undergo autonomic function tests (AFTs) for VD, hydrogen/methane breath testing (HBT) for...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
August 3 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2026
Estimated Enrollment :
55 Patients enrolled
Trial Details
Trial ID
NCT04353778
Start Date
August 3 2020
End Date
January 31 2026
Last Update
February 11 2025
Active Locations (1)
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1
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029