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

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 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

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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name