Recruiting
Phase 4

Observational Study

Sponsor:

Vanderbilt University Medical Center

Code:

NCT05550194

Conditions

Achalasia

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

ValACYclovir 1000 MG

Shingrix

Study Details

Brief summary:

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.

Conditions

Achalasia

Study ID

NCT05550194

Start date

Mar 27, 2023

Status verified date

Oct, 2026

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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.

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

ValACYclovir 1000 MG

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

Shingrix

Vaccine indicated for prevention of herpes zoster

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Michael McGill, BS

6153224643michael.g.mcgill@vumc.org

Amy Motley, BS

6153226281amy.motley@vumc.org

Locations

Vanderbilt University Medical Center

Recruiting

Nashville, Tennessee, United States, 37129

Contacts

Michael McGill

615-322-4643michael.g.mcgill@vumc.org

Amy Motley

615-322-6281amy.motley@vumc.org

More Information

Sponsor

Vanderbilt University Medical Center

Last update posted

Oct 5, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-24. This information was provided to ClinicalTrials.gov by Vanderbilt University Medical Center on 2026-10-05. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.