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Completed

NCT Number: NCT03862092

Frequency of Putative Enteric Zoster Diagnosed Using Saliva Samples in Patients With Abdominal Pain: a Prospective Study

The aim of this study is to identify the frequency of enteric zoster using salivary varicella zoster virus (VZV) DNA PCR in patients who visit the emergency room due to acute abdominal pain.

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Key information

Conditions

Abdominal Pain Chickenpox DNA Virus Infections Herpesviridae Infections Infections Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Varicella Zoster Virus Infection Virus Diseases Zoster With Other Complications

Age range

18 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Asan Medical Center, University of Ulsan College of Medicine

Seoul, 138-736, South Korea

About this study

Varicella zoster virus (VZV) infects and establishes latency in neurons in the ganglia of the cranial nerve, dorsal root, and enteric ganglia. VZV reactivation in enteric neurons (enteric zoster) can cause nonspecific abdominal pain and/or serious gastrointestinal dysfunction without cutaneous manifestations. Detection of VZV DNA in saliva may be useful for identifying enteric zoster. We evaluated the frequency of putative enteric zoster based on the presence of salivary VZV DNA in patients with acute abdominal pain.

Adult patients who visited the emergency room due to moderate to severe acute abdominal pain were prospectively enrolled at a tertiary hospital between May 2019 and November 2019. Abdominopelvic computed tomography (APCT) was performed in all patients. Saliva samples were collected from all studied patients. Enteric zoster was suspected based on the presence of salivary VZV DNA, detected using real-time polymerase chain reaction (PCR).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients aged ≥ 18, and < 80 years
  • ER-visited patients with acute abdominal pain
  • Numerical rating scale (NRS) score ≥ 4
  • Unresponsive to gastrointestinal motility drug, antacid

Exclusion criteria

  • Unwilling or unable to give informed consent forms
  • Patients taking antiviral agents
  • Patients complaining mild abdominal pain (NRS score ≤ 3)

Treatment and study plan

Salivary VZV-DNA PCR

Diagnostic Test

VZV-DNA PCR of saliva samples

Primary outcomes

  1. Frequency of enteric zoster in patients with acute abdominal pain

    Time frame: At the time of enrolled.

    The frequency of putative enteric zoster in patients with acute abdominal pain regardless of their underlying diseases

Sponsors and collaborators

Lead sponsor

Asan Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 5, 2019
Registry last updated
Sep 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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