UMIN-CTR Clinical Trial

Basic information
Public title	Verification of intestinal environment improvement and effect on cold symptoms by amazake long-term intake
Acronym	Verification of intestinal environment improvement and effect on cold symptoms by amazake long-term intake
Scientific Title	Verification of intestinal environment improvement and effect on cold symptoms by amazake long-term intake
Scientific Title:Acronym	Verification of intestinal environment improvement and effect on cold symptoms by amazake long-term intake
Region	Japan

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

Objectives
Narrative objectives1	Verification of intestinal environment improvement and effect on cold symptoms by amazake long-term intake
Basic objectives2	Others
Basic objectives -Others	Verification of effect on bowel movement by amazake long-term intake
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	alteration of intensional bacterial flora and effect on cold symptoms
Key secondary outcomes	Bowel movement

Base
Study type	Interventional

Study design
Basic design	Parallel
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	2
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Amazake made by rice koji and sake lees is taken once a day
Interventions/Control_2	Placebo drink of control 3 is taken once a 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	Male and Female
Key inclusion criteria	1) Regular visitors to Matsuike Clinic (those with mild constipation who are prescribed magnesium oxide) or healthy adults recruited by expressing their intention to participate directly with the investigator. 2) Those who are 20 to 60 years old at the time of obtaining consent to participate in the exam 3) Those who have received sufficient explanation about the purpose and contents of this test, have the ability to consent, voluntarily volunteer to participate after understanding it well, and can consent to participate in this test in writing. 4) Those who can come to the hospital on the designated date and receive interviews 5) Those who the investigator deems appropriate to participate in this study
Key exclusion criteria	1) Persons with symptoms other than mild constipation 2) Those who cannot be judged by the investigator as having no influence on the participation in the examination regarding the medical history 3) Persons who may cause allergic symptoms to the ingredients contained in the test food 4) Those who habitually consume amazake (regardless of manufacturer) 5) Those planning to become pregnant, lactating or possibly pregnant and pregnant during the study period 6) Persons with alcoholism or other mental disorders 7) Persons who may change their lifestyle during the examination period (night shift, long-term travel, etc.) 8) Those who plan to take new health foods and supplement foods during the test period 9) Those who have been treated with hospitalization within the past 6 months 10) Those who are currently participating in other human clinical trials, those who have not passed 3 months since participating in other human clinical trials 11) Others who are judged by the investigator to be inappropriate for this study
Target sample size	100

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.
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	NPO MINS
Address	401 5-20-9 mita minato-ku Tokyo
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	2021 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Partially published

Result
URL related to results and publications
Number of participants that the trial has enrolled	82
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	2020 Year 11 Month 11 Day
Date of IRB	2020 Year 11 Month 12 Day
Anticipated trial start date	2020 Year 11 Month 25 Day
Last follow-up date	2021 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 05 Month 06 Day
Last modified on	2022 Year 02 Month 18 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048570