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

NCT ID: NCT03862092

Last Updated: 2020-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-24

Study Completion Date

2019-12-31

Brief Summary

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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

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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).

Conditions

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Abdominal Pain Zoster With Other Complications

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patients with acute abdominal pain

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

Group Type EXPERIMENTAL

Salivary VZV-DNA PCR

Intervention Type DIAGNOSTIC_TEST

VZV-DNA PCR of saliva samples

Interventions

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Salivary VZV-DNA PCR

VZV-DNA PCR of saliva samples

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Asan Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Sung-Han Kim

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sung-Han Kim, MD.PhD

Role: PRINCIPAL_INVESTIGATOR

Asan Medical Center

Locations

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Asan Medical Center, University of Ulsan College of Medicine

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type BACKGROUND
PMID: 24509782 (View on PubMed)

Dworkin RH, Johnson RW, Breuer J, Gnann JW, Levin MJ, Backonja M, Betts RF, Gershon AA, Haanpaa ML, McKendrick MW, Nurmikko TJ, Oaklander AL, Oxman MN, Pavan-Langston D, Petersen KL, Rowbotham MC, Schmader KE, Stacey BR, Tyring SK, van Wijck AJ, Wallace MS, Wassilew SW, Whitley RJ. Recommendations for the management of herpes zoster. Clin Infect Dis. 2007 Jan 1;44 Suppl 1:S1-26. doi: 10.1086/510206.

Reference Type BACKGROUND
PMID: 17143845 (View on PubMed)

Gilden DH, Kleinschmidt-DeMasters BK, LaGuardia JJ, Mahalingam R, Cohrs RJ. Neurologic complications of the reactivation of varicella-zoster virus. N Engl J Med. 2000 Mar 2;342(9):635-45. doi: 10.1056/NEJM200003023420906. No abstract available.

Reference Type BACKGROUND
PMID: 10699164 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8179298 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19327938 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24092852 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18260763 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29029120 (View on PubMed)

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.

Reference Type DERIVED
PMID: 33830871 (View on PubMed)

Other Identifiers

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2014-1186

Identifier Type: -

Identifier Source: org_study_id

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