UMIN-CTR Clinical Trial

Basic information
Public title	Verification of intestinal environment improvement by amazake intake
Acronym	Verification of intestinal environment improvement by amazake intake
Scientific Title	Verification of intestinal environment improvement by amazake intake
Scientific Title:Acronym	Verification of intestinal environment improvement by amazake intake
Region	Japan

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

Objectives
Narrative objectives1	To verify intestinal environment improvement function of amazake
Basic objectives2	Others
Basic objectives -Others	To examine how the habit of drinking amazake affects the intestinal environment (intensional bacterial flora) that changes with the medication of mild constipation.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	alteration of intensional bacterial flora
Key secondary outcomes	Bowel movement

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	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Amazake made by rice koji is taken once a day for 4 weeks
Interventions/Control_2	Placebo drink of control 1 is taken once a day for 4 weeks
Interventions/Control_3	Amazake made by rice koji and sake lees is taken once a day for 4 weeks
Interventions/Control_4	Placebo drink of control 3 is taken once a day for 4 weeks
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	Male and Female
Key inclusion criteria	1) Regular visitor of Matsuo Clinic 2) Women with mild constipation who are prescribed magnesium oxide whose age at the time of obtaining consent to participate in the study is 20 to 60 years old (20 to 60 years old) 3) Those who have received sufficient explanation about the purpose and content of this study, have the ability to consent, volunteered to participate voluntarily after understanding well, and can agree to participate in this study in writing 4) Those who can visit the hospital on the designated day and can receive an inquiry 5) Those who are deemed appropriate by the study investigator to participate in this study
Key exclusion criteria	1) Persons with symptoms other than mild constipation 2) Persons who have no visit history for the past 3 months 3) Those who cannot be judged by the investigator without affecting the participation in the study 4) Those who may cause allergic symptoms to ingredients in test food 5) People who drink amazake (regardless of manufacturer) 6) Those who plan to become pregnant, breast-feeding, or possibly pregnant, and pregnant during the study period 7) Persons with alcoholism or other mental disorders 8) Persons who may change their lifestyle during the test period (night work, long trip, etc.) 9) Those who are planning to take health functional foods or supplement foods during the study period 10) Those who have been treated with hospitalization within the past 6 months 11) Persons currently participating in other human clinical trials, those who have not passed 3 months since participating in other human clinical trials 12) Other persons who are deemed inappropriate by the study investigator
Target sample size	20

Research contact person
Name of lead principal investigator	1st name sadao Middle name Last name mori
Organization	MORINAGA & CO., LTD.
Division name	R & D Center
Zip code	230-8504
Address	2-1-1 Shimosueyoshi Turumi-ku Yokohama, Kanagawa
TEL	045-571-6140
Email	s-mori-ab@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 Center
Zip code	230-8504
Address	2-1-1 Shimosueyoshi Turumi-ku Yokohama, Kanagawa
TEL	045-571-6140
Homepage URL
Email	s-mori-ab@morinaga.co.jp

Sponsor
Institute	MORINAGA & CO., LTD.
Institute
Department

Funding Source
Organization	MORINAGA & CO., LTD. R & D Center
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	NPO MINS
Address	401 5-20-9 mita minato-ku Tokyo
Tel	03-6416-1868
Email	03-6416-1869

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

Other administrative information
Date of disclosure of the study information	2019 Year 10 Month 18 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications	http://lifescience.co.jp/yk/yk20/ykj2007.html
Number of participants that the trial has enrolled	25
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	2019 Year 09 Month 19 Day
Date of IRB	2019 Year 09 Month 19 Day
Anticipated trial start date	2019 Year 10 Month 17 Day
Last follow-up date	2020 Year 01 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 10 Month 17 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=R000043677