UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043015 |
|---|---|
| Receipt number | R000044627 |
| Scientific Title | Effect of habitual amazake consumption on intestinal environment |
| Date of disclosure of the study information | 2021/01/15 |
| Last modified on | 2021/01/15 14:28:49 |
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Basic information
Public title
Effect of habitual amazake consumption on intestinal environment
Acronym
Effect of habitual amazake consumption on intestinal environment
Scientific Title
Effect of habitual amazake consumption on intestinal environment
Scientific Title:Acronym
Effect of habitual amazake consumption on intestinal environment
Region
| Japan |
Condition
Condition
Relief of constipation
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To observe the elimination of the dynamics and the constipation of the intestinal bacteria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation 4 weeks after ingestion
Key secondary outcomes
Microbiota 4 weeks after ingestion
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Amazake 35g/day for 4 weeks
Interventions/Control_2
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
| 19 | years-old | <= |
Age-upper limit
| 22 | years-old | >= |
Gender
Female
Key inclusion criteria
1, Understand the menstrual cycle
2, Amazake can be consumed
Key exclusion criteria
1,a person with a history of allergies to Amazake
2,a person with menstrual irregular
Target sample size
33
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Irie |
Organization
Okayama Prefectural University
Division name
Faculty of Health and Welfare Science
Zip code
71-1197
Address
111 Kuboki, Soja-shi, Okayama
TEL
0866-94-2111
yirie@fhw.oka-pu.ac.jp
Public contact
Name of contact person
| 1st name | Rikako |
| Middle name | |
| Last name | Inoue |
Organization
Okayama Prefectural University
Division name
Faculty of Health and Welfare Science
Zip code
71-1197
Address
111 Kuboki, Soja-shi, Okayama
TEL
0866-94-2111
Homepage URL
rinoue@fhw.oka-pu.ac.jp
Sponsor or person
Institute
Okayama Prefectural University
Faculty of Health and Welfare Science
Institute
Department
Personal name
Funding Source
Organization
Okayama Prefectural University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Prefectural University
Address
111 Kuboki, Soja-shi, Okayama
Tel
0866-94-2111
rinoue@fhw.oka-pu.ac.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | 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
30
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
| 2017 | Year | 06 | Month | 01 | Day |
Date of IRB
| 2017 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2017 | Year | 07 | Month | 30 | Day |
Last follow-up date
| 2020 | Year | 03 | 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
| 2021 | Year | 01 | Month | 15 | Day |
Last modified on
| 2021 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044627
