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VZV in the Enteric Nervous System: Pathogenesis and Consequences

This study is looking into whether the varicella zoster virus (VZV), which causes chickenpox and shingles, also causes achalasia. Achalasia is a serious condition where food has trouble moving from your esophagus to your stomach. Researchers believe a chronic VZV infection in the nerves of the bowel, sometimes called "enteric shingles," might be linked to achalasia. This study will give participants either ValACYclovir 1000 MG, an antiviral medication targeting VZV, or the Shingrix vaccine, which prevents shingles. The goal is to see if treating VZV can improve achalasia. They are looking for 40 participants, aged 18 to 75, who have achalasia and are fluent in English. The main goal is to see how achalasia responds to anti-VZV treatment after 4 months. The current recruitment status is unclear.

Study design
This is an interventional study with a planned enrollment of 40 participants. The phase of the study is not specified.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at 4 months, indicating a follow-up period of at least that long.

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NCT05550194

VZV in the Enteric Nervous System: Pathogenesis and Consequences

Recruiting
PHASE4Ages 18–75InterventionalTreatment
Vanderbilt University Medical Center
~40 participants
Updated 2026-05-27 on ClinicalTrials.gov
What's tested:ValACYclovir 1000 MGShingrix

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response of VZV-associated achalasia to anti-VZV therapy.
Measured over 4 months

Conditions

Achalasia

Explore related trials

Achalasia

Where it's being run

1 sites across 1 states
Tennessee1

Study leadership

  • Michael Vaezi, MD · PRINCIPAL_INVESTIGATOR · Vanderbilt University Medical Center

Who to contact

Michael McGill, BS
[email protected]
6153224643
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Eligibility criteria

Inclusion

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.
Based on standard clinical practice, we anticipate that patients who undergo these treatments will have been formally diagnosed with achalasia and will be fit to undergo the selected treatment intervention.
All subjects must be able to undergo timed barium swallow testing, trans-nasal intubation for high-resolution manometry probe, and therapeutic intervention of a 2-month course of valacyclovir 1g TID and two injections of Shingrix over a two-month period.

Exclusion

Unstable medical illness with ongoing diagnostic work-up and treatment. Patients with well-controlled hypertension, diabetes and a remote history of ischemic heart disease that is deemed stable, as judged by the physician-investigator can be included.
Current neurologic or cognitive impairment which would make the patient an unsuitable candidate for a research trial.

What this trial measures

  • Response of VZV-associated achalasia to anti-VZV therapy.4 months

    Response will be measured by the Eckardt score. The Eckardt score is the sum of the symptom scores for dysphagia, regurgitation, and chest pain (with a score of 0 indicating the absence of symptoms, 1 indicating occasional symptoms, 2 indicating daily symptoms, and 3 indicating symptoms at each meal) and weight loss (with 0 indicating no weight loss, 1 indicating a loss of \<5 kg, 2 indicating a loss of 5 to 10 kg, and 3 indicating a loss of \>10 kg).