Actively Recruiting
VZV in the Enteric Nervous System: Pathogenesis and Consequences
Led by Vanderbilt University Medical Center · Updated on 2025-05-16
40
Participants Needed
1
Research Sites
174 weeks
Total Duration
On this page
Sponsors
V
Vanderbilt University Medical Center
Lead Sponsor
C
Columbia University
Collaborating Sponsor
AI-Summary
What this Trial Is About
Varicella zoster virus (VZV) is the cause of chickenpox and shingles, but it also infects, becomes latent, and reactivates in nerve cells of the bowel to cause a gastrointestinal disorder ("enteric shingles"). The Investigators recently found that a chronic active VZV infection, a form of enteric shingles, is associated with achalasia, a severe disease in which the passage of food from esophagus to stomach is impaired. We now propose to eradicate VZV to determine whether its association with achalasia is causal, to identify the genetic basis behind VZV reactivation in the esophagus, and the relationship of mast cells to enteric shingles and abdominal pain.
CONDITIONS
Official Title
VZV in the Enteric Nervous System: Pathogenesis and Consequences
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female subjects aged 18-75 years old inclusive (females of childbearing potential should be on highly effective contraceptive methods)
- Fluent in English and mentally capable to provide informed consent who present to Vanderbilt University Medical Center Digestive Diseases Center for treatment of achalasia
- Patients formally diagnosed with achalasia and fit to undergo selected treatment intervention
- Able to undergo timed barium swallow testing, trans-nasal intubation for high-resolution manometry, and a 2-month course of valacyclovir 1g three times daily plus two Shingrix injections over two months
You will not qualify if you...
- Unstable medical illness with ongoing diagnostic work-up and treatment (well-controlled hypertension, diabetes, and stable ischemic heart disease allowed as judged by the physician-investigator)
- Current neurologic or cognitive impairment making the patient unsuitable for research participation
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37129
Actively Recruiting
Research Team
M
Michael McGill, BS
CONTACT
A
Amy Motley, BS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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