Clinical trial NCT03862092: Frequency of Putative Enteric Zoster Diagnosed Using Saliva Samples in Patients With Abdominal Pain: a Prospective Study
Official title: Frequency of Putative Enteric Zoster Diagnosed Using Saliva Samples in Patients With Abdominal Pain: a Prospective Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Abdominal Pain
Zoster With Other Complications
Keywords: varicella zoster virus
enteric zoster
saliva
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2019-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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)

Primary outcomes:
measure: Frequency of enteric zoster in patients with acute abdominal pain
timeFrame: At the time of enrolled.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center, University of Ulsan College of Medicine
Study officials:
affiliation: Asan Medical Center
name: Sung-Han Kim, MD.PhD
role: PRINCIPAL_INVESTIGATOR
References:
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