UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061978 |
|---|---|
| Receipt number | R000070918 |
| Scientific Title | A prospective observational study of comprehensive microbiome and metabolome profiling in infected walled-off necrosis and the impact of antimicrobial and antifungal therapy |
| Date of disclosure of the study information | 2026/06/19 |
| Last modified on | 2026/06/19 15:26:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comprehensive analysis of bacterial flora and metabolome in necrotic tissue of infected walled-off necrosis, and the effects of antibiotics and antifungal drugs: a prospective observational study
Acronym
WON-MICRO
Scientific Title
A prospective observational study of comprehensive microbiome and metabolome profiling in infected walled-off necrosis and the impact of antimicrobial and antifungal therapy
Scientific Title:Acronym
WON-MICRO prospective study
Region
| Japan |
Condition
Condition
Infected walled-off necrosis
Classification by specialty
| Hepato-biliary-pancreatic medicine | Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate longitudinal changes in microbiome composition (bacteria by 16S rRNA gene sequencing, fungi by ITS1 sequencing) and microbial metabolite profiles (by untargeted LC-MS/MS metabolomics) in necrotic tissue of infected walled-off necrosis (WON), and to evaluate the impact of antibiotic and antifungal therapy on the local microbial and metabolic environment.
Basic objectives2
Others
Basic objectives -Others
Pathophysiological investigation (longitudinal microbiome and metabolome profiling)
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Longitudinal changes in bacterial microbiome composition (alpha diversity, beta diversity, and taxonomic profiles assessed by 16S rRNA gene amplicon sequencing) and microbial metabolite profiles (assessed by untargeted LC-MS/MS metabolomics) in necrotic tissue collected at each necrosectomy procedure.
Key secondary outcomes
1. Association between antibiotic/antifungal use (type and duration) and longitudinal changes in microbiome composition.
2. Fungal microbiome composition assessed by ITS1 sequencing and the impact of antifungal therapy.
3. Concordance rate between conventional culture-based pathogen identification and 16S rRNA gene sequencing.
4. Association between microbiome/metabolome profiles and clinical outcomes (treatment success rate, in-hospital mortality, and major complication rates).
5. Detection and quantitative evaluation of antimicrobial resistance genes in necrotic tissue.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Age 18 years or older
2. Diagnosed with infected walled-off necrosis (WON)
3. Scheduled for endoscopic treatment including necrosectomy or drainage
4. Able to provide written informed consent (patients with severely impaired consciousness at or shortly after admission may be enrolled via opt-out procedure)
Key exclusion criteria
1. Age under 18 years
2. Patients who have explicitly refused participation in the study
3. Patients deemed inappropriate for participation at the investigator's discretion
4. Patients in whom specimen collection is judged medically difficult or inappropriate due to severe systemic condition or organ failure
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takeya |
| Middle name | |
| Last name | Tsutsumi |
Organization
The University of Tokyo Hospital
Division name
Department of Infection Control and Prevention
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
takeyatsutsumi@g.ecc.u-tokyo.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Kishida |
Organization
The University of Tokyo Hospital
Division name
Department of Infectious Diseases
Zip code
113-8655
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655, Japan
TEL
03-3815-5411
Homepage URL
https://utid.info/study.html
tkishida@g.ecc.u-tokyo.ac.jp
Sponsor or person
Institute
The University of Tokyo
Institute
Department
Personal name
Takeya Tsutsumi
Funding Source
Organization
The University of Tokyo
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics Committee of Graduate School of Medicine and Faculty of Medicine, The University of Tokyo
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-0033, Japan
Tel
03-5841-0818
ethics@m.u-tokyo.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
東京大学医学部附属病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 06 | Month | 19 | Day |
Related information
URL releasing protocol
https://utid.info/study.html
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
Individual participant data will not be shared.
IPD sharing Plan description
All specimens and information collected in this study will be managed with linked anonymization. Individual participant data will not be provided to third parties in order to protect personal information. Research findings will be disseminated through academic publications and conference presentations in the form of anonymized aggregate data.
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 10 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 17 | Day |
Anticipated trial start date
| 2025 | Year | 11 | Month | 10 | Day |
Last follow-up date
| 2030 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2030 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2030 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2031 | Year | 03 | Month | 31 | Day |
Other
Other related information
Ethics review number: 2025351NI-(1) (Ethics Committee of Graduate School of Medicine and Faculty of Medicine, The University of Tokyo)
This is a single-center prospective observational study conducted at the University of Tokyo Hospital.
Management information
Registered date
| 2026 | Year | 06 | Month | 19 | Day |
Last modified on
| 2026 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070918
