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

Primary Purpose

Abdominal Pain, Zoster With Other Complications

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Salivary VZV-DNA PCR
Sponsored by
Asan Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Abdominal Pain focused on measuring varicella zoster virus, enteric zoster, saliva

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Asan Medical Center, University of Ulsan College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Patients with acute abdominal pain

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
March 2, 2019
Last Updated
September 22, 2020
Sponsor
Asan Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT03862092
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
November 19, 2019 (Actual)
Study Completion Date
December 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Asan Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Pain, Zoster With Other Complications
Keywords
varicella zoster virus, enteric zoster, saliva

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Patients with acute abdominal pain
Arm Type
Experimental
Arm Description
Salivary VZV-DNA PCR was performed in patients who visited the emergency room due to acute abdominal pain.
Intervention Type
Diagnostic Test
Intervention Name(s)
Salivary VZV-DNA PCR
Intervention Description
VZV-DNA PCR of saliva samples
Primary Outcome Measure Information:
Title
Frequency of enteric zoster in patients with acute abdominal pain
Description
The frequency of putative enteric zoster in patients with acute abdominal pain regardless of their underlying diseases
Time Frame
At the time of enrolled.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sung-Han Kim, MD.PhD
Organizational Affiliation
Asan Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Asan Medical Center, University of Ulsan College of Medicine
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24509782
Citation
Zerboni L, Sen N, Oliver SL, Arvin AM. Molecular mechanisms of varicella zoster virus pathogenesis. Nat Rev Microbiol. 2014 Mar;12(3):197-210. doi: 10.1038/nrmicro3215. Epub 2014 Feb 10.
Results Reference
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PubMed Identifier
10699164
Citation
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PubMed Identifier
8179298
Citation
Gilden DH, Wright RR, Schneck SA, Gwaltney JM Jr, Mahalingam R. Zoster sine herpete, a clinical variant. Ann Neurol. 1994 May;35(5):530-3. doi: 10.1002/ana.410350505.
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PubMed Identifier
19327938
Citation
Edelman DA, Antaki F, Basson MD, Salwen WA, Gruber SA, Losanoff JE. Ogilvie syndrome and herpes zoster: case report and review of the literature. J Emerg Med. 2010 Nov;39(5):696-700. doi: 10.1016/j.jemermed.2009.02.010. Epub 2009 Mar 27.
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PubMed Identifier
24092852
Citation
Gershon AA, Gershon MD. Pathogenesis and current approaches to control of varicella-zoster virus infections. Clin Microbiol Rev. 2013 Oct;26(4):728-43. doi: 10.1128/CMR.00052-13.
Results Reference
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PubMed Identifier
18260763
Citation
Mehta SK, Tyring SK, Gilden DH, Cohrs RJ, Leal MJ, Castro VA, Feiveson AH, Ott CM, Pierson DL. Varicella-zoster virus in the saliva of patients with herpes zoster. J Infect Dis. 2008 Mar 1;197(5):654-7. doi: 10.1086/527420.
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PubMed Identifier
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Citation
Park SY, Kim JY, Kim JA, Kwon JS, Kim SM, Jeon NY, Kim MC, Chong YP, Lee SO, Choi SH, Kim YS, Woo JH, Kim SH. Diagnostic Usefulness of Varicella-Zoster Virus Real-Time Polymerase Chain Reaction Analysis of DNA in Saliva and Plasma Specimens From Patients With Herpes Zoster. J Infect Dis. 2017 Dec 27;217(1):51-57. doi: 10.1093/infdis/jix508.
Results Reference
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PubMed Identifier
33830871
Citation
Ra SH, Kwon JS, Kim JY, Cha HH, Lee HJ, Jung J, Kim MJ, Chong YP, Lee SO, Choi SH, Kim YS, Kim WY, Kim SH. Frequency of putative enteric zoster diagnosed using saliva samples in patients with abdominal pain: a prospective study. Infect Dis (Lond). 2021 Sep;53(9):713-718. doi: 10.1080/23744235.2021.1908593. Epub 2021 Apr 8.
Results Reference
derived

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

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