Small Bowel Bacterial Overgrowth Clinical Trials

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Effects of Vagal Dysfunction on Gastrointestinal and Inflammatory Pathways in HIV

Who is this study for? People living with HIV
Status: Recruiting
Location: See location...
Intervention Type: Drug, Procedure
Study Type: Interventional
Study Phase: Phase 1/Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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)

Locations
United States
New York
Icahn School of Medicine at Mount Sinai
RECRUITING
New York
Contact Information
Primary
Niyati Neupane
niyati.neupane@mssm.edu
Backup
Mary Catherine George, MM, PhD
mary-catherine.george@mssm.edu
212-241-0784
Time Frame
Start Date: 2020-08-03
Estimated Completion Date: 2026-09-16
Participants
Target number of participants: 207
Treatments
No_intervention: PLWH
People living with HIV (HIV)
No_intervention: Healthy Controls
Healthy controls who do not have HIV
Active_comparator: Pyridostigmine
PLWH on pyridostigmine 30mg PO TID
Placebo_comparator: Placebo
PLWH on placebo
Other: nVNS
PLWH to undergo non-invasive vagal nerve stimulation
Sponsors
Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Leads: Icahn School of Medicine at Mount Sinai

This content was sourced from clinicaltrials.gov