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

Not Applicable

Completed

• Conditions: Zoster With Other Complications; Abdominal Pain
• Interventions: Diagnostic Test: Salivary VZV-DNA PCR

• Registration Number: NCT03862092
• Lead Sponsor: Asan Medical Center

Brief Summary

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2019-03-02
• Study First Submitted QC: 2019-03-02
• Study First Posted: 2019-03-05
• Study Start: 2019-04-24
• Primary Completion: 2019-11-19
• Study Completion: 2019-12-31
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-22
• Last Update Posted: 2020-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with acute abdominal pain	Salivary VZV-DNA PCR	Salivary VZV-DNA PCR was performed in patients who visited the emergency room due to acute abdominal pain.

Primary Outcome Measures

Name	Time	Method
Frequency of enteric zoster in patients with acute abdominal pain	At the time of enrolled.	The frequency of putative enteric zoster in patients with acute abdominal pain regardless of their underlying diseases

Trial Locations

Locations (1)

Asan Medical Center, University of Ulsan College of Medicine; 🇰🇷 Seoul, Korea, Republic of