Ignite Creation Date:
2025-12-24 @ 3:35 PM
Ignite Modification Date:
2026-01-05 @ 5:51 PM
Study NCT ID:
NCT03862092
Status:
COMPLETED
Last Update Posted:
2020-09-24
First Post:
2019-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Frequency of Putative Enteric Zoster Diagnosed Using Saliva Samples in Patients With Abdominal Pain: a Prospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015746', 'term': 'Abdominal Pain'}, {'id': 'D002644', 'term': 'Chickenpox'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D000073618', 'term': 'Varicella Zoster Virus Infection'}, {'id': 'D006566', 'term': 'Herpesviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D007239', 'term': 'Infections'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-22', 'studyFirstSubmitDate': '2019-03-02', 'studyFirstSubmitQcDate': '2019-03-02', 'lastUpdatePostDateStruct': {'date': '2020-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of enteric zoster in patients with acute abdominal pain', 'timeFrame': 'At the time of enrolled.', 'description': 'The frequency of putative enteric zoster in patients with acute abdominal pain regardless of their underlying diseases'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['varicella zoster virus', 'enteric zoster', 'saliva'], 'conditions': ['Abdominal Pain', 'Zoster With Other Complications']}, 'referencesModule': {'references': [{'pmid': '24509782', 'type': 'BACKGROUND', '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.'}, {'pmid': '17143845', 'type': 'BACKGROUND', 'citation': '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.'}, {'pmid': '10699164', 'type': 'BACKGROUND', '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. doi: 10.1056/NEJM200003023420906. No abstract available.'}, {'pmid': '8179298', 'type': 'BACKGROUND', '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.'}, {'pmid': '19327938', 'type': 'BACKGROUND', '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.'}, {'pmid': '24092852', 'type': 'BACKGROUND', '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.'}, {'pmid': '18260763', 'type': 'BACKGROUND', '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.'}, {'pmid': '29029120', 'type': 'BACKGROUND', '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.'}, {'pmid': '33830871', 'type': 'DERIVED', '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAdult 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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '79 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged ≥ 18, and \\< 80 years\n* ER-visited patients with acute abdominal pain\n\n * Numerical rating scale (NRS) score ≥ 4\n * Unresponsive to gastrointestinal motility drug, antacid\n\nExclusion Criteria:\n\n* Unwilling or unable to give informed consent forms\n* Patients taking antiviral agents\n* Patients complaining mild abdominal pain (NRS score ≤ 3)'}, 'identificationModule': {'nctId': 'NCT03862092', 'briefTitle': 'Frequency of Putative Enteric Zoster Diagnosed Using Saliva Samples in Patients With Abdominal Pain: a Prospective Study', 'organization': {'class': 'OTHER', 'fullName': 'Asan Medical Center'}, 'officialTitle': 'Frequency of Putative Enteric Zoster Diagnosed Using Saliva Samples in Patients With Abdominal Pain: a Prospective Study', 'orgStudyIdInfo': {'id': '2014-1186'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Patients with acute abdominal pain', 'description': 'Salivary VZV-DNA PCR was performed in patients who visited the emergency room due to acute abdominal pain.', 'interventionNames': ['Diagnostic Test: Salivary VZV-DNA PCR']}], 'interventions': [{'name': 'Salivary VZV-DNA PCR', 'type': 'DIAGNOSTIC_TEST', 'description': 'VZV-DNA PCR of saliva samples', 'armGroupLabels': ['Patients with acute abdominal pain']}]}, 'contactsLocationsModule': {'locations': [{'zip': '138-736', 'city': 'Seoul', 'country': 'South Korea', 'facility': 'Asan Medical Center, University of Ulsan College of Medicine', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'overallOfficials': [{'name': 'Sung-Han Kim, MD.PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Asan Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Asan Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Sung-Han Kim', 'investigatorAffiliation': 'Asan Medical Center'}}}}