UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033241 |
|---|---|
| Receipt number | R000037900 |
| Scientific Title | influence of intake of Aspellugirus oryzae containing food on disorder of defecation accompanying menstrual cycle of Japanese female in twenties. |
| Date of disclosure of the study information | 2018/07/30 |
| Last modified on | 2021/03/05 12:20:00 |
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Basic information
Public title
influence of intake of Aspellugirus oryzae containing food on disorder of defecation accompanying menstrual cycle of Japanese female in twenties.
Acronym
Disorder of defecation accompanying sexual cycle of Japanese female in twenties
Scientific Title
influence of intake of Aspellugirus oryzae containing food on disorder of defecation accompanying menstrual cycle of Japanese female in twenties.
Scientific Title:Acronym
Disorder of defecation accompanying sexual cycle of Japanese female in twenties
Region
| Japan |
Condition
Condition
Bowel movement with menstrual cycle
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine how food intake affects disturbance of defecation accompanying menstrual cycle.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
There is a possibility that the number of bacteria in feces may fluctuate by ingesting food.
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Analyze the disturbance of defecation accompanying the sexual cycle with or without food ingestion.
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
| 29 | years-old | > |
Gender
Female
Key inclusion criteria
Japanese women in their twenties
Key exclusion criteria
Not having any medicine on menstruation
Target sample size
135
Research contact person
Name of lead principal investigator
| 1st name | wakana |
| Middle name | |
| Last name | noriaki |
Organization
Tokyo university of agriculture
Division name
Faculty of Applied Bioscience, Department of Nutritional Science
Zip code
156-8502
Address
Sakuragaoka setagayaku Tokyo
TEL
03-5477-257
n3wakana-tua@umin.ac.jp
Public contact
Name of contact person
| 1st name | wakana |
| Middle name | |
| Last name | noriaki |
Organization
Tokyo university of agriculture
Division name
Faculty of Applied Bioscience, Department of Nutritional Science
Zip code
156-8502
Address
sakuragaoka setagayaku Tokyo
TEL
03-5477-2547
Homepage URL
n3wakana-tua@umin.ac.jp
Sponsor or person
Institute
tokyo university of agriculture
Institute
Department
Personal name
Funding Source
Organization
No
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
Tokyo University of Agriculture
Address
1-1-1, Sakuragaoka, Setagaya-ku, Tokyo
Tel
03-5477-2456
n3wakana-tua@umin.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
| 2018 | Year | 07 | Month | 30 | 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
15
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
Completed
Date of protocol fixation
| 2018 | Year | 07 | Month | 30 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 30 | Day |
Anticipated trial start date
| 2018 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2021 | 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
| 2018 | Year | 07 | Month | 02 | Day |
Last modified on
| 2021 | Year | 03 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037900
