UMIN-CTR Clinical Trial

Basic information
Public title	Bowel movement improving test by consumption of "BARLEYmax"
Acronym	Bowel movement improving test by consumption of "BARLEYmax"
Scientific Title	A study of bowel movement improving effect by consumption of super barley "BARLEYmax"
Scientific Title:Acronym	A study of bowel movement improving effect by consumption of super barley "BARLEYmax"
Region	Japan

Condition
Condition	Chronic constipation
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To verify the bowel movement improving effect by consumption of functional barley (super barley "BARLEYmax", by means of questionnaire.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	*Comparison using-dose fluctuation of the laxative (Magnesium oxidative) between before consumption and after consumption by questionnaire. *Comparison the number of defecation between before consumption and after consumption by questionnaire. *Comparison the amount of defecation between before consumption and after consumption by questionnaire. *Comparison the feces properties (hardness of feces) between before consumption and after consumption by questionnaire. *Comparison the feelings after defecation between before consumption and after consumption by questionnaire. *Comparison the health condition between before consumption and after consumption by questionnaire.
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	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake steamed barley containing 12g of functional barley (super barley "BARLEYmax") every day for one month. The timing of intake isn't specified.
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1) Males and females aged 20 and older. 2) Subjects who have received medical examination due to constipation and use magnesium oxidative as laxative. 3) Subjects who receive enough explain of the test, who deeply understanding of the test, and who obtain own consent to participate the test.
Key exclusion criteria	Subjects who have received medical examination due to constipation but who don't use Magnesium oxidative as laxative.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Tsuneo Middle name Last name Matsuike
Organization	Matsuike Clinic
Division name	Director
Zip code	190-0021
Address	2-12-27, Hagoromo-cho, Tachikawa-city, Tokyo 190-0021, JAPAN
TEL	042-522-7713
Email	IRB@cpcc.co.jp

Public contact
Name of contact person	1st name Kunihiro Middle name Last name Matsuura
Organization	Integrate co.,ltd.
Division name	Integrated Solution Division
Zip code	151-0051
Address	Park Avenue, 1-20-1, Sendagaya, Shibuya-ku, Tokyo 151-0051, JAPAN
TEL	03-5771-9960
Homepage URL
Email	k.matsuura@itgr.co.jp

Sponsor
Institute	Matsuike Clinic
Institute
Department

Funding Source
Organization	TEIJIN LIMITED
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Institutional Review Board of Chiyoda Paramedical Care Clinic
Address	2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel	03-5297-5548
Email	IRB@cpcc.co.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	2019 Year 04 Month 08 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	Completed
Date of protocol fixation	2019 Year 03 Month 15 Day
Date of IRB	2019 Year 03 Month 15 Day
Anticipated trial start date	2019 Year 04 Month 08 Day
Last follow-up date	2019 Year 07 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	2019 Year 03 Month 27 Day
Last modified on	2020 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041377