Actively Recruiting
VZV in the Enteric Nervous System: Pathogenesis and Consequences
Led by Vanderbilt University Medical Center · Updated on 2026-05-27
40
Participants Needed
1
Research Sites
N/A
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), known for causing chickenpox and shingles, can also infect nerve cells in the digestive system, leading to a condition called enteric shingles. Researchers found that a chronic active VZV infection in the esophagus may be linked to achalasia, a severe disorder that affects the movement of food from the esophagus to the stomach. This study aims to explore whether treating VZV can improve achalasia symptoms, identify genetic factors related to VZV reactivation in the esophagus, and understand the role of mast cells in this condition. Participants with achalasia who test positive for VZV DNA in their saliva will receive valacyclovir, an antiviral medication, taken three times daily for two months. Those who benefit from this treatment will be offered the Shingrix vaccine in two doses during the same period. The study will assess how antiviral therapy affects achalasia symptoms and esophageal function, compare viral loads between achalasia types, and investigate the involvement of mast cells in VZV reactivation. Throughout the study, participants will undergo tests including timed barium swallow and esophageal manometry to evaluate esophageal function. Researchers will monitor viral activity, genetic markers, and symptoms related to achalasia over four months to one year. The main outcome is the response of VZV-associated achalasia to antiviral treatment within four months, with additional measures tracking viral load differences, genetic findings, and mast cell activity over one year. The total participation period extends up to a year to fully understand the treatment effects and disease mechanisms.
CONDITIONS
Brief Title
VZV in the Enteric Nervous System: Pathogenesis and Consequences
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male and female adults aged 18 to 75 years inclusive
- Females of childbearing potential must use highly effective contraception
- Fluent in English and mentally able to provide informed consent
- Diagnosed with achalasia and fit for treatment at Vanderbilt University Medical Center
- Able to undergo timed barium swallow testing and trans-nasal intubation for esophageal manometry
- Willing to complete a 2-month course of valacyclovir 1g three times daily and receive two doses of Shingrix vaccine
You will not qualify if you...
- Unstable medical illness under ongoing diagnostic work-up and treatment
- Current neurologic or cognitive impairment making the patient unsuitable for research participation
- Well-controlled hypertension, diabetes, or stable ischemic heart disease are allowed as judged by physician-investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 2 months
Participants with achalasia and VZV DNA in saliva receive valacyclovir three times daily for 2 months to treat VZV-associated achalasia. Participants who benefit from valacyclovir treatment will be offered two doses of the Shingrix vaccine.
Visits as needed during treatment for medication management and monitoring
Duration - Up to 1 year
Participants are monitored for response to treatment and changes in achalasia symptoms and viral load for up to 4 months after treatment initiation. Additional assessments for viral load, genetic typing, and mast cell activation may occur up to one year.
Periodic visits for up to 1 year
Trial Site Locations
Total: 1 location
1
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37129
Actively Recruiting
Research Team
M
Michael McGill, BS
A
Amy Motley, BS
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here