UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061984 |
|---|---|
| Receipt number | R000070928 |
| Scientific Title | Study on the effect of continuous ingestion of a material for preventing urinary tract infection (1-deoxymannose) on the host microbiome (gut and vaginal) and urinary excretion dynamics |
| Date of disclosure of the study information | 2026/06/24 |
| Last modified on | 2026/06/20 08:22:06 |
* 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
Study on the effect of continuous ingestion of a material for 1-deoxy-D-mannose on the host microbiome (gut and vaginal) and urinary excretion dynamics
Acronym
Effect of continuous 1-deoxy-D-mannose ingestion on host microbiome and urinary excretion
Scientific Title
Study on the effect of continuous ingestion of a material for preventing urinary tract infection (1-deoxymannose) on the host microbiome (gut and vaginal) and urinary excretion dynamics
Scientific Title:Acronym
Effect of continuous 1-deoxymannose ingestion on microbiome and urinary excretion
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the long-term effects and efficacy of 1-deoxy-D-mannose (DM) on the human body by conducting a continuous ingestion experiment of DM, and evaluating changes in the host microbiome (gut and verginal), and urinary DM excretion before and after ingestion.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
Changes in gut microbiome and vaginal microbiome before and after 4 weeks (28 days) of continuous 1-deoxy-D-mannose ingestion
Key secondary outcomes
Changes in urinary 1-deoxymannose excretion before and after 4 weeks (28 days) of continuous 1-deoxy-D-mannnose ingestion
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Duration: 29 days (1 day of pre-ingestion evaluation + 27 days of continuous ingestion + 1 day of post-ingestion evaluation)
Test materials: 1-deoxy-D-mannose
Dose: 1.0 g
Administration: Take once a day. On the 1st day (before continuous ingestion) and the 29th day (after continuous ingestion), the test material is ingested for evaluation, and 24-hour urine is collected. In addition, self-collection of feces and vaginal secretions is performed between 2 days before and the day of each evaluation test. During the 27 days in between, it is continuously ingested once a day.
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
| 20 | years-old | <= |
Age-upper limit
| 30 | years-old | > |
Gender
Female
Key inclusion criteria
Healthy Japanese female adults
Key exclusion criteria
The exclusion criteria are a history of diabetes mellitus, abnormal glucose metabolism, respiratory disease, chronic gastrointestinal disease, abnormal bowel movements, food allergies, urinary tract infection, or cystitis. Those with a BMI of 25.0 or higher. Those who routinely consume non-digestible and absorbable saccharides such as dietary fiber, or pharmaceuticals (e.g., antibiotics). Those with extreme menstrual irregularity.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Kenichi |
| Middle name | |
| Last name | Tanabe |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka
TEL
092-851-2598
tanabek@nakamura-u.ac.jp
Public contact
Name of contact person
| 1st name | Kenichi |
| Middle name | |
| Last name | Tanabe |
Organization
Nakamura Gakuen University
Division name
Faculty of Nutritional Sciences
Zip code
814-0198
Address
5-7-1 Befu, Jonan-ku, Fukuoka
TEL
092-851-2598
Homepage URL
tanabek@nakamura-u.ac.jp
Sponsor or person
Institute
Nakamura Gakuen University
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Jumonji University and Kagoshima University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nakamura Gakuen University
Address
5-7-1 Befu, Jonan-ku, Fukuoka
Tel
092-851-2598
tanabek@nakamura-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
| 2026 | Year | 06 | Month | 24 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 06 | Month | 18 | Day |
Date of IRB
| 2026 | Year | 06 | Month | 18 | Day |
Anticipated trial start date
| 2026 | Year | 06 | Month | 24 | Day |
Last follow-up date
| 2028 | Year | 03 | 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 | 06 | Month | 20 | Day |
Last modified on
| 2026 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070928
