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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044117
Receipt No. R000048570
Scientific Title Verification of intestinal environment improvement and effect on cold symptoms by amazake long-term intake
Date of disclosure of the study information 2021/06/30
Last modified on 2021/10/15

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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 Completed
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
2021 Year 10 Month 15 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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