UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059106 |
|---|---|
| Receipt number | R000067617 |
| Scientific Title | Elucidating the association between the etiology of pediatric acute appendicitis and oral Fusobacterium |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/09/17 13:01:51 |
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Basic information
Public title
The relationship between pediatric acute appendicitis and periodontal bacteria
Acronym
Pediatric appendicitis and periodontal bacteria
Scientific Title
Elucidating the association between the etiology of pediatric acute appendicitis and oral Fusobacterium
Scientific Title:Acronym
Pediatric appendicitis and Fusobacterium
Region
| Japan |
Condition
Condition
Aute appendicitis
Classification by specialty
| Gastroenterology | Surgery in general | Gastrointestinal surgery |
| Pediatrics | Dental medicine | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Elucidating the etiology of pediatric acute appendicitis
Basic objectives2
Others
Basic objectives -Others
Elucidation of etiology
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Identification of Fusobacterium strains as potential causative agents of pediatric acute appendicitis
Key secondary outcomes
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
| 6 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Disease group Patients undergoing appendectomy for a diagnosis of acute appendicitis
Control group Patients diagnosed with inguinal hernia related conditions, undescended testis, umbilical hernia, pectus excavatum, or phimosis
Key exclusion criteria
Individuals with a history of appendicitis
Individuals undergoing elective appendectomy
Individuals who have used antibiotics or probiotics within the past month
Children with severe motor and intellectual disabilities
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kouji |
| Middle name | |
| Last name | Masumoto |
Organization
University of Tsukuba Hospital
Division name
Department of Pediatric Surgery
Zip code
3058576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
TEL
0298533900
kmasu@md.tsukuba.ac.jp
Public contact
Name of contact person
| 1st name | Tsubasa |
| Middle name | |
| Last name | Aiyoshi |
Organization
University of Tsukuba Hospital
Division name
Department of Pediatric Surgery
Zip code
3058576
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
TEL
0298533900
Homepage URL
t.aiyoshi@md.tsukuba.ac.jp
Sponsor or person
Institute
University of Tsukuba
Institute
Department
Personal name
Funding Source
Organization
Other
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board (IRB) of the University of Tsukuba Hospital
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
Tel
0298533900
t-credo.adm@un.tsukuba.ac.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 | 10 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2025 | Year | 08 | Month | 26 | Day |
Anticipated trial start date
| 2025 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2029 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
To identify Fusobacterium strains that may be causative agents of pediatric acute appendicitis and investigate their pathogenicity.
Management information
Registered date
| 2025 | Year | 09 | Month | 17 | Day |
Last modified on
| 2025 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067617
