UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000057295 |
|---|---|
| Receipt number | R000065496 |
| Scientific Title | A study of the association between varicella-zoster virus (VZV) in patients with esophageal motility disorder |
| Date of disclosure of the study information | 2025/03/15 |
| Last modified on | 2026/07/30 07:04:59 |
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Basic information
Public title
A study of the association between varicella-zoster virus (VZV) in patients with esophageal motility disorder
Acronym
A study of the association between varicella-zoster virus (VZV) in patients with esophageal motility disorder
Scientific Title
A study of the association between varicella-zoster virus (VZV) in patients with esophageal motility disorder
Scientific Title:Acronym
A study of the association between varicella-zoster virus (VZV) in patients with esophageal motility disorder
Region
| Japan |
Condition
Condition
esophageal motility disorder
Classification by specialty
| Hepato-biliary-pancreatic medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To determine the association between esophageal motility disorders and VZV reactivation by studying saliva from patients with esophageal motility disorders and normal subjects for the presence of VZV infection.
Basic objectives2
Others
Basic objectives -Others
Assessment of Pathophysiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary VZV-DNA, VZV-IgM, VZV-IgG, Results of High Resolution Manometry
Key secondary outcomes
Age, gender, onset of esophageal motility disorder, history, history of VZV vaccination
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The applicant must satisfy all of the following 1) to 2).
1) Patients who have undergone esophageal endopressure test at the Department of Gastroenterology, Chiba University Hospital.
2) Patients who have received a full explanation of their participation in this study, and who have given written consent of their own free will based on full understanding.
Key exclusion criteria
1) Those who have expressed their refusal to participate in this research through the information disclosure document
2) Other persons deemed unsuitable by the principal investigator.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Tomoaki |
| Middle name | |
| Last name | Matsumura |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2648677
Address
1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture
TEL
0432227171
matsumura@chiba-u.jp
Public contact
Name of contact person
| 1st name | Satsuki |
| Middle name | |
| Last name | Takahashi |
Organization
Chiba University Hospital
Division name
Gastroenterology
Zip code
2648677
Address
1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture
TEL
0432227171
Homepage URL
takahashi-satsuki@chiba-u.jp
Sponsor or person
Institute
Chiba University
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiba University Hospital
Address
1-8-1 Inohana, Chuo Ward, Chiba City, Chiba Prefecture
Tel
0432227171
takahashi-satsuki@chiba-u.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 03 | Month | 15 | Day |
Related information
URL releasing protocol
https://pubmed.ncbi.nlm.nih.gov/40788375/
Publication of results
Published
Result
URL related to results and publications
https://pubmed.ncbi.nlm.nih.gov/40788375/
Number of participants that the trial has enrolled
72
Results
32 (44.4%) were in the normal group and 40 (55.6%) were in the EMD group, including 22 with esophagogastric junction (EGJ) outflow disorders and 18 with peristalsis disorders. One patient with absent contractility had a concurrent herpes zoster infection, and VZV DNA was detected in this patient's saliva. However, all other patients tested negative for VZV DNA. No significant difference in VZV antibody titers was observed between the two groups.
Results date posted
| 2026 | Year | 07 | Month | 30 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2025 | Year | 08 | Month | 11 | Day |
Baseline Characteristics
Of the 78 patients who underwent HRM, six were excluded due to missing blood test data. A total of 72 patients were included in our analysis, of whom, 40 (55.6%) were male. The median age was 59 years. The primary indications were as follows: dysphagia or suspected achalasia in 21 patients (29.2%), non-cardiac chest pain in 15 (20.8%), GERD symptoms in 14 (19.4%), laryngopharyngeal reflux symptoms in 9 (12.5%), follow-up after peroral endoscopic myotomy (POEM) or pneumatic dilation in 4 (5.6%), and other indications in 9 (12.5%). The normal group comprised 32 (44.4%) of the sample. The remaining 40 (55.6%) were in the EMD group. The EMD group included 22 patients with EGJ outflow disorders and 18 with peristalsis disorders.
Participant flow
Patients who underwent high-resolution manometry (HRM) for the evaluation of suspected esophageal abnormalities at Chiba University Hospital between May 2022 and July 2024 were included. Patients who did not provide consent to participate in the study and those younger than 20 years were excluded. Saliva and blood samples were collected from all participants, who also completed a questionnaire regarding their history of varicella, herpes zoster, and VZV vaccination. Patients with active herpes zoster were excluded from the main analysis.
Based on the HRM findings, patients were classified into a normal group and an esophageal motility disorder (EMD) group. The EMD group was further stratified into patients with esophagogastric junction (EGJ) outflow disorders and those with peristaltic disorders.
Adverse events
nothing
Outcome measures
DNA concentration
VZV-IgM titers
VZV-IgG titers
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2022 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2022 | Year | 05 | Month | 06 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2025 | Year | 03 | Month | 15 | Day |
Last modified on
| 2026 | Year | 07 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065496
