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

Abdominal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03862092
• Other study ID #: 2014-1186
• Status: Completed
• Phase: N/A
• Start date: April 24, 2019
• Est. completion date: December 31, 2019

Study information

• Verified date: September 2020
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 31, 2019
• Est. primary completion date: November 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

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)

Related Conditions & MeSH terms

• Abdominal Pain
• Herpes Zoster
• Zoster With Other Complications

Intervention

Diagnostic Test:
• Salivary VZV-DNA PCR
VZV-DNA PCR of saliva samples

Locations

Country	Name	City	State
Korea, Republic of	Asan Medical Center, University of Ulsan College of Medicine	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Asan Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (8)

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. Review. — View 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. Review. — View 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. Review. — View Citation

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. Review. Erratum in: N Engl J Med 2000 Apr 6;342(14):1063. — View 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. Review. — View 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	At the time of enrolled.