Investigating the role of Varicella zoster virus in achalasia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to explore the connection between Varicella zoster virus (VZV) and achalasia, a condition that impairs food passage from the esophagus to the stomach. Researchers will administer a treatment regimen of valacyclovir and Shingrix to patients diagnosed with achalasia to determine if eradicating VZV can alleviate symptoms. The study will also investigate the genetic factors behind VZV reactivation in the esophagus and the role of mast cells in enteric shingles and abdominal pain. Participants will undergo various diagnostic tests to assess the presence of VZV and its impact on their condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• Vanderbilt University Medical Center
  Nashville, Tennessee, United States Recruiting

Study contacts

• Principal investigator: Michael Vaezi, MD — Vanderbilt University Medical Center
• Study coordinator: Michael McGill, BS
• Email: michael.g.mcgill@vumc.org
• Phone: 6153224643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Indocyanine green fluorescence during laparoscopic Heller–Dor for achalasia

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.