VZV in the Enteric Nervous System: Pathogenesis and Consequences

Launched by VANDERBILT UNIVERSITY MEDICAL CENTER · Sep 19, 2022

Keywords

ClinConnect Summary

This clinical trial is studying the role of the varicella zoster virus (VZV), which is known for causing chickenpox and shingles, in a condition called achalasia. Achalasia is a serious problem where the esophagus has trouble moving food down to the stomach. Researchers want to find out if VZV infections in the nerves of the bowel are causing achalasia and to explore the genetic factors that might lead to this virus reactivating. They will also look at how certain immune cells, known as mast cells, might relate to stomach pain in these patients.

To participate in this study, you need to be between 18 and 75 years old, fluent in English, and able to give informed consent. You must have a diagnosis of achalasia and be fit for specific tests and treatments. Participants will undergo tests to measure how well they can swallow and will receive a two-month course of a medication called valacyclovir, along with two vaccinations. The trial is currently recruiting participants at Vanderbilt University Medical Center, and it’s important to note that some medical conditions might prevent someone from joining. Overall, this study could help improve our understanding and treatment of achalasia.

Gender

ALL

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.