UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043015
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email rinoue@fhw.oka-pu.ac.jp

Sponsor
Institute Okayama Prefectural University
Faculty of Health and Welfare Science
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044627

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.