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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000033241
Receipt No. 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 2019/07/05

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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
Email 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
Email n3wakana-tua@umin.ac.jp

Sponsor
Institute tokyo university of agriculture
Institute
Department

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
Email 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 No longer recruiting
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
2019 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037900

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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