NCT05550194 VZV in the Enteric Nervous System: Pathogenesis and Consequences
| NCT ID | NCT05550194 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Vanderbilt University Medical Center |
| Condition | Achalasia |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-03-27 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 40 participants in total. It began in 2023-03-27 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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.
Contact & Investigator
Michael Vaezi, MD
PRINCIPAL INVESTIGATOR
Vanderbilt University Medical Center
Frequently Asked Questions
Who can join the NCT05550194 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Achalasia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05550194 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05550194 currently recruiting?
Yes, NCT05550194 is actively recruiting participants. Contact the research team at michael.g.mcgill@vumc.org for enrollment information.
Where is the NCT05550194 trial being conducted?
This trial is being conducted at Nashville, United States.
Who is sponsoring the NCT05550194 clinical trial?
NCT05550194 is sponsored by Vanderbilt University Medical Center. The principal investigator is Michael Vaezi, MD at Vanderbilt University Medical Center. The trial plans to enroll 40 participants.