Actively Recruiting

Phase 4
Age: 18Years - 75Years
All Genders
ID05550194

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

Age: 18Years - 75Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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

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