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

September 22, 2020 updated by: Sung-Han Kim, Asan Medical Center
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 138-736
        • Asan Medical Center, University of Ulsan College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 79 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Patients with acute abdominal pain
Salivary VZV-DNA PCR was performed in patients who visited the emergency room due to acute abdominal pain.
Diagnostic test: Salivary VZV-DNA PCR
VZV-DNA PCR of saliva samples

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At the time of enrolled.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asan Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 24, 2019

Primary Completion (ACTUAL)

November 19, 2019

Study Completion (ACTUAL)

December 31, 2019

Study Registration Dates

First Submitted

March 2, 2019

First Submitted That Met QC Criteria

March 2, 2019

First Posted (ACTUAL)

March 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 22, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014-1186

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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