UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058405 |
|---|---|
| Receipt number | R000066772 |
| Scientific Title | A Study on the Effects of Medicinal Mouthwash Use on Oral Bacterial Species in Patients with Chronic Glomerulonephritis |
| Date of disclosure of the study information | 2025/07/09 |
| Last modified on | 2025/07/08 20:01:25 |
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Basic information
Public title
A Study on the Effects of Medicinal Mouthwash Use on Oral Bacterial Species in Patients with Chronic Glomerulonephritis
Acronym
A Study on the Effects of Medicinal Mouthwash Use on Oral Bacterial Species
Scientific Title
A Study on the Effects of Medicinal Mouthwash Use on Oral Bacterial Species in Patients with Chronic Glomerulonephritis
Scientific Title:Acronym
A Study on the Effects of Medicinal Mouthwash Use on Oral Bacterial Species
Region
| Japan |
Condition
Condition
IgA nephropathy, Membranous nephropathy, Lupus nephritis, Focal segmental glomerulosclerosis (FSGS)
Classification by specialty
| Nephrology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aims to investigate whether the use of ConCool F, a medicated mouthwash, by patients with chronic kidney disease (CKD) not only reduces oral bacteria but also has the potential to decrease proteinuria.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Reduction in oral bacterial count, Reduction in proteinuria, Reduction in hematuria
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
Gurgling with mouthwash for 1 years
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients receiving care at the Department of Nephrology, Seirei Hamamatsu Hospital, or Department of General Internal Medicine, Hyogo Medical University. Men and women aged 20 years or older who have been diagnosed with IgA nephropathy, membranous nephropathy, lupus nephritis, or focal segmental glomerulosclerosis, and who have proteinuria of 0.3 g/gCr or more on two consecutive occasions and an estimated glomerular filtration rate (eGFR) of 25 mL/min/1.73 m2 or more.
Key exclusion criteria
Patients with IgA vasculitis will be excluded. Patients with suspected secondary IgA nephropathy, such as those with rheumatoid arthritis or Crohn's disease, will also be excluded. Patients with HbA1c 6.5% or more or those receiving antidiabetic medications other than SGLT2 inhibitors will be excluded. If the dosage of steroids or immunosuppressive drugs is increased during the period, the patient will be excluded from the study.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Nakano |
Organization
Graduate School of Dentistry, The University of Osaka
Division name
Joint Research Laboratory of Science for Oral and Systemic Connection
Zip code
5650871
Address
1-8 Yamadaoka, Suita, Osaka, Japan
TEL
0668792962
nakano.kazuhiko.dent@osaka-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuto |
| Middle name | |
| Last name | Suehiro |
Organization
Graduate School of Dentistry, The University of Osaka
Division name
Joint Research Laboratory of Science for Oral and Systemic Connection
Zip code
5650871
Address
1-8 Yamadaoka, Suita, Osaka, Japan
TEL
0668792962
Homepage URL
suehiro.yuto.dent@osaka-u.ac.jp
Sponsor or person
Institute
The University of Osaka
Institute
Department
Personal name
Funding Source
Organization
Weltec Corp.
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
the institutional review board and ethics committee of Osaka University Dental Hospital
Address
1-8 Yamadaoka, Suita, Osaka, Japan
Tel
0668795111
si-soumu-syomu@office.osaka-u.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 | 07 | Month | 09 | 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
| 2025 | Year | 01 | Month | 30 | Day |
Date of IRB
| 2025 | Year | 03 | Month | 31 | Day |
Anticipated trial start date
| 2025 | Year | 04 | Month | 08 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 07 | Month | 08 | Day |
Last modified on
| 2025 | Year | 07 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066772
