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VZV in the Enteric Nervous System: Pathogenesis and Consequences

ConditionAchalasia
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-75
SponsorVanderbilt University Medical Center

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • ValACYclovir 1000 MG

    Drug

    Valacyclcovir is a targeted anti-viral for varicella zoster virus (VZV).

  • Shingrix

    Biological/Vaccine

    Vaccine indicated for prevention of herpes zoster

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: TreatmentExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Response of VZV-associated achalasia to anti-VZV therapy.

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).

Time frame
4 months

Secondary outcomes

1

Difference in viral loads in achalasia phenotype II versus phenotype III

Difference in viral load will be measured by real-time qPCR to quantify VZV transcripts (ORF40, ORF67) to estimate the severity of VZV infection.

Time frame
One year
2

Genetic typing of reactivation of VZV in the esophagus

Next-generation sequencing will generate whole VZV genomes from the low amounts of DNA found in clinical samples for VZV genotyping

Time frame
One year
3

Incidence of reactivation of VZV due to mast cell degranulation

Number of subjects found to have mast cell disorder

Time frame
One year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Vanderbilt University Medical Center

Lead sponsor

Columbia University

Collaborator

Source ClinicalTrials.gov
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