VZV in the Enteric Nervous System: Pathogenesis and Consequences

Part of paid clinical trials in Nashville, Tennessee.

Sponsor
Vanderbilt University Medical Center
Study ID
NCT05550194
Phase
PHASE4
Status
Recruiting
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Conditions

  • Achalasia

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • ValACYclovir 1000 MG — DRUG
    Valacyclcovir is a targeted anti-viral for varicella zoster virus (VZV).
  • Shingrix — BIOLOGICAL
    Vaccine indicated for prevention of herpes zoster

Study Details

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.

Key Dates

Start date
Mar 27, 2023
Status verified
May 2026
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment
    Patients with Achalasia (phenotypes II and III) with VZV DNA in saliva. Patients will be treated with valacyclovir 3 times per day. Patients found to benefit from treatment with valacyclovir will be offered Shingrix vaccine (2 - 0.5mL doses)

Primary Outcome Measure

Response of VZV-associated achalasia to anti-VZV therapy. [ Time Frame: 4 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Vanderbilt University Medical CenterNashvilleTennessee37129
Michael McGill
[email protected]
615-322-4643
Amy Motley
[email protected]
615-322-6281

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By research site
Vanderbilt University Medical Center· Nashville, TN

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