UMIN-CTR Clinical Trial

Basic information
Public title	Verification study of Bowel Movement Improvement by Amazake Consumption
Acronym	Verification study of Bowel Movement Improvement by Amazake Consumption
Scientific Title	Verification study of Bowel Movement Improvement by Amazake Consumption
Scientific Title:Acronym	Verification study of Bowel Movement Improvement by Amazake Consumption
Region	Japan

Condition
Condition	Not applicable
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification study of Bowel Movement Improvement by Amazake Consumption
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	number of bowel movements per day, amount of stools, strength of odor, state of the stool, sensation after defecation per bowel movement.
Key secondary outcomes	number of tablets of the magnesium carbonate which ingested per day

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	190g of Amazake using the lees and rice koji, 1 bottle per day
Interventions/Control_2	190g of hot water, 1 cup per day
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	60 years-old >
Gender	Female
Key inclusion criteria	1) Person who regular visits at Matsuo Clinic 2) Women with mild constipation who are prescribed magnesium oxide at the age of 20 to 60 years at the time of obtaining informed consent for study participation 3) Person who have be given sufficient explanation about the purpose and contents of this study, has the ability to agree, volunteer for voluntary participation with good understanding, and can consent to this examination in writing 4) Person who can come to the Matsuike Clinic on the designated day and receive an interview 5) Person who were considered appropriate to participate in this study by the study doctor
Key exclusion criteria	1) Person who have symptoms other than mild constipation 2) Person who is no history of visits for the past 3 months 3) Person who have some factor that the examining physician can not judge the affect to the study 4) Person who may be allergic to the test food ingredients 5) Person who regularly drink sweet sake (manufacturer is not matter) 6) Person who plan pregnancy, lactation or pregnancy possibility and pregnancy during the study period 7) Person with alcoholism or other mental disorders 8) Person who may change lifestyle during the examination period (night work, long trips, etc.) 9) Person who are planning to take health functional food or supplement food during the test period 10) Person who received treatment with hospitalization within the past 6 months 11) Person who are currently participating in other clinical trials, or person who have not passed three months after participating in other clinical trials 12) Person who the study doctor judged as inappropriate for this study
Target sample size	40

Research contact person
Name of lead principal investigator	1st name Minoru Middle name Last name Morita
Organization	Morinaga & CO., LTD.
Division name	R & D institute
Zip code	230-8514
Address	2-1-1, shimosueyoshi, tsurumi-ku, yokohama, kanagawa, 230-8504 Japan
TEL	045-571-2982
Email	m-morita-je@morinaga.co.jp

Public contact
Name of contact person	1st name Sadao Middle name Last name Mori
Organization	Morinaga & CO., LTD.
Division name	R & D institute
Zip code	230-8514
Address	2-1-1, shimosueyoshi, tsurumi-ku, yokohama, kanagawa, 230-8504 Japan
TEL	045-571-2982
Homepage URL
Email	s-mori-ab@morinaga.co.jp

Sponsor
Institute	Morinaga & CO., LTD.
Institute
Department

Funding Source
Organization	Morinaga & CO., LTD.
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	Non-Profit Organization MINS Institutional Review Board
Address	5-20-9-401,Mita,Minato-ku,Tokyo,Japan
Tel	03-6416-1868
Email	npo-mins@j-irb.com

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	松生クリニック（東京都）

Other administrative information
Date of disclosure of the study information	2019 Year 03 Month 15 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	38
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	Main results already published
Date of protocol fixation	2018 Year 05 Month 17 Day
Date of IRB	2018 Year 05 Month 17 Day
Anticipated trial start date	2018 Year 06 Month 01 Day
Last follow-up date	2018 Year 12 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 14 Day
Last modified on	2020 Year 08 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040765