UMIN-CTR Clinical Trial

Basic information
Public title	Improvement effect of substance X on human bowel movement.
Acronym	Improvement effect of substance X on human bowel movement.
Scientific Title	Improvement effect of substance X on human bowel movement.
Scientific Title:Acronym	Improvement effect of substance X on human bowel movement.
Region	Japan

Condition
Condition	Tendency for constipation
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the improvement effect of beverages containing substance X on human constipation
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Defecation days, defecation frequency
Key secondary outcomes	1)Amount of feces, fecal condition (form, color, smell, feeling after defecation) 2)Change of subjective symptoms of intolerance to cold

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	4
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Test beverage A (contaning low-dose X) for 2-week intake -> 2-week washout -> Placebo beverage (control) for 2-week intake
Interventions/Control_2	Placebo beverage (control) for 2-week intake -> 2-week washout -> Test beverage A for 2-week intake
Interventions/Control_3	Test beverage B (contaning high-dose X) for 2-week intake -> 2-week washout -> Placebo beverage (control) for 2-week intake
Interventions/Control_4	Placebo beverage (control) for 2-week intake -> 2-week washout -> Test beverage B for 2-week intake
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1)Healthy Japanese Subjects. 2)Subjects with tendency for constipation (at 4 times or less of defecation per week). 3)Subjects who take regular meals.
Key exclusion criteria	1)Subjects with medical history of severe disorders. 2)Subjects with continuous medical treatment. 3)Subjects with surgical history of digestive system (except appendectomy). 4)Subjects who take any kind of medicine (intestinal, laxative medicine etc) regularly that possibly affect bowel movement. 5) Subjects who take supplements and/or functional foods (including Food for Specified Health Uses [FOSHU] regularly that possibly affect bowel movement. 6)Pregnant or have possibility to become pregnant during the study or lactating women. 7)Subjects who drink alcohol a lot regularly. 8)Subjects who judged as unsuitable for this study by the principal investigator for any reasons.
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Yuki Middle name Last name Ishida
Organization	Hayashibara CO., LTD.
Division name	R & D Division, Development Unit
Zip code	7028006
Address	675-1, Fujisaki, Naka-ku, Okayama
TEL	086-276-3141
Email	yuki.ishida@hb.nagase.co.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Ishida
Organization	Hayashibara CO., LTD.
Division name	R & D Division, Development Unit
Zip code	7028006
Address	675-1, Fujisaki, Naka-ku, Okayama
TEL	086-276-3141
Homepage URL
Email	yuki.ishida@hb.nagase.co.jp

Sponsor
Institute	Medical Corporation Hokubukai, Utsukushigaoka Hospital
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	The Medical Corporation Hokubu-kai Utsukushigaoka Hospital
Address	61-1, Shinei, Kiyota-ku, Sapporo
Tel	011-882-0111
Email	wakimoto@ughp-cpc.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	医療法人北武会　美しが丘病院 (北海道) / Medical Corporation Hokubukai, Utsukushigaoka Hospital (Hokkaido)

Other administrative information
Date of disclosure of the study information	2016 Year 09 Month 20 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	40
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	2016 Year 09 Month 09 Day
Date of IRB	2016 Year 09 Month 15 Day
Anticipated trial start date	2016 Year 09 Month 21 Day
Last follow-up date	2016 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete	2017 Year 01 Month 20 Day
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 20 Day
Last modified on	2020 Year 01 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027756