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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031191
Receipt No. R000035609
Scientific Title A study for evaluating the efficacy of Yeast drink
Date of disclosure of the study information 2018/02/07
Last modified on 2018/03/26

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Basic information
Public title A study for evaluating the efficacy of Yeast drink
Acronym A study for evaluating the efficacy of Yeast drink
Scientific Title A study for evaluating the efficacy of Yeast drink
Scientific Title:Acronym A study for evaluating the efficacy of Yeast drink
Region
Japan

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

Objectives
Narrative objectives1 To verify the effects of the intestinal flora with the intake of Yeast drink in four weeks.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

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

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 Dilute the test food (20ml) 6 to 7 times with water or hot water.Drink it twice a day (after breakfast and after 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
60 years-old >
Gender Male and Female
Key inclusion criteria 1. Male and female aged from 20 to 59 yeas old.
2. Healthy adults (those without serious organ disorders or specific diseases, those who have not received treatment).
3. Constipation as 3 to 5 times a week of week.
4. Those who are constipated for more than 3 months.
5. Those who obtains written consent.
Key exclusion criteria 1. Those who has serious or progressive disease or symptom.
2. Those who are currently ongoing drug treatment (urgent acceptable).
3. Those who take health foods and dietary supplements regularly for intestinal health.
4. Drug Allergy/Food Allergy.
5. Pregnant,lactating,pregnant wishing during the test period.
6. Those who participated in other clinical trials within one month.
7. Those who considered inappropriate as the
subject of this trial by the principal investigator.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazumasa Tada
Organization The First Yeast Co.Ltd.
Division name Senior Managing Director
Zip code
Address 261-1,Naka,Izunokuni,Shizuoka,Japan
TEL 055-940-3050
Email k-tada@dream.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazumasa Tada
Organization The First Yeast Co.Ltd.
Division name Senior Managing Director
Zip code
Address 261-1,Naka,Izunokuni,Shizuoka,Japan
TEL 055-940-3050
Homepage URL
Email k-tada@dream.ocn.ne.jp

Sponsor
Institute The First Yeast Co.Ltd.
Institute
Department

Funding Source
Organization The First Yeast Co.Ltd.
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2018 Year 02 Month 07 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
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
2018 Year 01 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 02 Month 07 Day
Last modified on
2018 Year 03 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035609

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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