Investigating the role of Varicella zoster virus in achalasia
VZV in the Enteric Nervous System: Pathogenesis and Consequences
This study is testing if a treatment that targets the chickenpox virus can help people with achalasia feel better by improving how food moves from the esophagus to the stomach.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Vanderbilt University Medical Center Academic / other |
| Locations | 1 site (Nashville, Tennessee) |
| Trial ID | NCT05550194 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with a formal diagnosis of achalasia who can undergo the required diagnostic procedures.
Not a fit: Patients with unstable medical conditions or those unable to participate in the necessary diagnostic tests may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a new treatment approach for patients suffering from achalasia linked to VZV infection.
How similar studies have performed: While the association between VZV and achalasia is being explored, this approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Nashville, Tennessee
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.