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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000043674
Receipt No. R000049873
Scientific Title A Study to Investigate the Effect of Ingestion of Drinks Containing Yeast on Bowel Movement
Date of disclosure of the study information 2021/03/19
Last modified on 2021/10/07

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Basic information
Public title A Study to Investigate the Effect of Ingestion of Drinks Containing Yeast on Bowel Movement
Acronym A Study to Investigate the Effect of Ingestion of Drinks Containing Yeast on Bowel Movement
Scientific Title A Study to Investigate the Effect of Ingestion of Drinks Containing Yeast on Bowel Movement
Scientific Title:Acronym A Study to Investigate the Effect of Ingestion of Drinks Containing Yeast on Bowel Movement
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the effect of continuous ingestion of drinks containing yeast on the bowel movement and the intestinal environment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes frequency and amount of stool,type of stool, conditions at defecation
Key secondary outcomes Fecal microflora

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 The study food diluted with water or lukewarm water will be ingested in two divided doses, after breakfast and dinner.
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
20 years-old <=
Age-upper limit
65 years-old >
Gender Male and Female
Key inclusion criteria 1.Age between 20 and 65 years at the time of informed consent
2.Healthy adults (those without serious organ disorders or specific diseases, those who have not received treatment).
3.Constipation as 2 to 5 times a week of week.
4.Those who are able to input electronic diary with smartphone / PC
5.Those who received sufficient explanation about the trial, volunteered to participate after understanding the purpose, and agree to participate in the trial with written consent
Key exclusion criteria 1.Those who has been currently visiting a hospital or treated with any drug or herbal remedy (however, dosing as needed is allowed) for any disease
2.On diet / exercise therapy under the guidance of a doctor
3.Have a current or history of serious illness
4.Are undergoing treatment for digestive disorders and constipation.
5.Have had gastrointestinal surgery (appendicitis is acceptable)
6.Take antiflatulent or laxatives daily
7.Take lactic acid bacteria drinks, yogurt or supplements containing lactic acid bacteria daily
8.Those who regularly ingest any food for specified health use, health food or supplement
9.Those who have a current or previous history of drug and/or food allergies
10.Planning to significantly change their lifestyle (diet, sleep, exercise, etc.) during the trial
11.Excessive consumption of alcohol (alcohol equivalent 60g or more / day)
12.Smokers (who have not been smoking for the last year)
13.Irregular diet, shift worker, night shift, irregular life rhythm
14.Those who are currently pregnant or breastfeeding or those who want to become pregnant during the test period
15.Participation in another clinical trial within one month of enrollment into the trial, participating currently or planning to participate
16.Those who were determined by the investigator to be unsuitable for participation in this clinical trial
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Kazumasa
Middle name
Last name Tada
Organization Daiichikobo Co., Ltd
Division name Senior Managing Director
Zip code 410-2113
Address 718-2 Nagoya Izunokuni-City Shizuoka Japan
TEL 055-978-3050
Email k-tada@dream.ocn.ne.jp

Public contact
Name of contact person
1st name Yoshitada
Middle name
Last name Hira
Organization IMEQRD Co., Ltd
Division name Sales department
Zip code 104-0061
Address 6-2-1 Ginza Chuo-ku Tokyo Japan
TEL 03-6704-5968
Homepage URL
Email y-hira@imeqrd.co.jp

Sponsor
Institute IMEQRD Co., Ltd
Institute
Department

Funding Source
Organization Daiichikobo 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 Suda Clinic institutional review board
Address 2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel 03-6704-5968
Email n-yuzawa@imeqrd.co.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 03 Month 19 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 20
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
2021 Year 03 Month 17 Day
Date of IRB
2021 Year 03 Month 16 Day
Anticipated trial start date
2021 Year 04 Month 17 Day
Last follow-up date
2021 Year 06 Month 12 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 03 Month 19 Day
Last modified on
2021 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049873

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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