UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061190 |
|---|---|
| Receipt number | R000070025 |
| Scientific Title | Efficacy of Oral Care with On-Demand Generated Chlorous Acid Ion Solution (MA-T) in Preventing Ventilator-Associated Pneumonia in Intubated ICU Patients: A Single-Center, Open-Label, Non-Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/04/07 |
| Last modified on | 2026/04/07 22:31:11 |
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Basic information
Public title
Efficacy of Oral Care with MA-T in Preventing Ventilator-Associated Pneumonia in Intubated ICU Patients
Acronym
MOUTH-CLEAN study
Scientific Title
Efficacy of Oral Care with On-Demand Generated Chlorous Acid Ion Solution (MA-T) in Preventing Ventilator-Associated Pneumonia in Intubated ICU Patients: A Single-Center, Open-Label, Non-Randomized Controlled Trial
Scientific Title:Acronym
MOUTH-CLEAN study
Region
| Japan |
Condition
Condition
Intubated patients in the intensive care unit
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether oral care using MA-T reduces the incidence of ventilator-associated pneumonia (VAP) compared with conventional oral care in intubated patients admitted to the ICU
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Ventilator-Associated Pneumonia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Oral care with conventional oral care kit mouthwash (6 ml) and mouth paste (2 g) for brushing.
Interventions/Control_2
Oral care using MA-T mouthwash (6 ml) and MA-T oral gel (2 g) for brushing, in place of conventional mouthwash and mouth paste.
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
Patients intubated and receiving mechanical ventilation
Key exclusion criteria
Patients extubated within 48 hours of intubation
Patients with oral or facial trauma
Patients at risk of oral bleeding due to coagulopathy, oral ulcers, or other conditions that may be exacerbated by frequent oral care
Patients capable of performing oral care independently
Patients with pneumonia as the primary diagnosis at admission
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Momoko |
| Middle name | |
| Last name | Sugimoto |
Organization
Tokyo Science University Hospital
Division name
Trauma and Acute Critical Care Center
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
momoko.sugi@gmail.com
Public contact
Name of contact person
| 1st name | Momoko |
| Middle name | |
| Last name | Sugimoto |
Organization
Tokyo Science University Hospital
Division name
Trauma and Acute Critical Care Center
Zip code
113-8519
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
TEL
03-3813-6111
Homepage URL
momoko.sugi@gmail.com
Sponsor or person
Institute
Tokyo Science University Hospital
Institute
Department
Personal name
Funding Source
Organization
Earth Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institute of Science Tokyo Clinical Research Review Board
Address
1-5-45, Yushima, Bunkyo-ku, Tokyo, Japan
Tel
03-3813-6111
rinri.adm@tmd.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
| 2026 | Year | 04 | Month | 07 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 01 | Month | 27 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 07 | Day |
Last modified on
| 2026 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070025
