Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
NCT05550194

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Trial Site Locations

Total: 1 location

1

Vanderbilt University Medical Center

Nashville, Tennessee, United States, 37129

Actively Recruiting

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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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