UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060777 |
|---|---|
| Receipt number | R000068873 |
| Scientific Title | A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Cranberry Extract on the Urinary Microbiome in Children with Nocturnal Enuresis |
| Date of disclosure of the study information | 2026/02/27 |
| Last modified on | 2026/02/27 17:03:46 |
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Basic information
Public title
KMU Cranberry On Nocturnal Enuresis for Continence Trial
Acronym
KMU CONNECT
Scientific Title
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Cranberry Extract on the Urinary Microbiome in Children with Nocturnal Enuresis
Scientific Title:Acronym
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Effect of Cranberry Extract on the Urinary Microbiome in Children with Nocturnal Enuresis
Region
| Japan |
Condition
Condition
Nocturnal enuresis
Classification by specialty
| Pediatrics | Child |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the changes in the urinary microbiome following continuous consumption of cranberry extract supplement in children with nocturnal enuresis.
Basic objectives2
Others
Basic objectives -Others
Relative abundance of urinary microbiota
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Relative abundance of urinary microbiota
Key secondary outcomes
Diversity of urinary microbiota
Urine pH
Hippuric acid concentration in urine
Frequency of nocturnal enuresis
Frequency of daytime urinary incontinence
Maximum voided volume
Fecal organic acid concentration
Gut microbiota diversity and functional prediction
Nocturnal urine volume
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will receive cranberry extract supplement (5 tablets) once daily for 3 weeks.
Interventions/Control_2
Participants will receive placebo (5 tablets) once daily for 3 weeks.
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
| 5 | years-old | <= |
Age-upper limit
| 15 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Children aged 5 to 15 years at the time of consent.
2) Outpatients.
3) Gender: Both male and female.
4) Diagnosed with nocturnal enuresis.
5) Patients from whom written informed consent has been obtained from the participant or their legal guardian after sufficient explanation and understanding.
Key exclusion criteria
Children who meet any of the following criteria:
1) Use of antibiotics within the last month.
2) Routine consumption of cranberries or cranberry products.
3) Presence of underlying renal or urinary tract diseases.
4) Refusal to participate in this study.
5) Otherwise judged unsuitable for the study by the principal investigator.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Shohei |
| Middle name | |
| Last name | Akagawa |
Organization
Kansai Medical University Hospital
Division name
Department of Pediatrics
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata City, Osaka Prefecture, Japan
TEL
072-804-0101
akagawa.sho@kmu.ac.jp
Public contact
Name of contact person
| 1st name | Shohei |
| Middle name | |
| Last name | Akagawa |
Organization
Kansai Medical University Hospital
Division name
Department of Pediatrics
Zip code
573-1191
Address
2-3-1 Shinmachi, Hirakata City, Osaka Prefecture, Japan
TEL
072-804-0101
Homepage URL
akagawa.sho@kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University
Institute
Department
Personal name
Funding Source
Organization
KAKENHI, Japan Society for the Promotion of Science
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
Ethics Review Center, Kansai Medical University
Address
Room 701, 7th Floor, 2-5-1 Shinmachi, Hirakata City, Osaka Prefecture, Japan
Tel
072-804-0101
rinriirb@hirakata.kmu.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 | 02 | Month | 27 | 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
| 2026 | Year | 02 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 02 | Month | 16 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 27 | Day |
Last follow-up date
| 2029 | 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 | 02 | Month | 27 | Day |
Last modified on
| 2026 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068873
