UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031191 |
|---|---|
| Receipt number | 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 | 2024/05/17 15:47:44 |
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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 | Kazumasa |
| Middle name | |
| Last name | Tada |
Organization
The First Yeast Co.Ltd.
Division name
Senior Managing Director
Zip code
410-2113
Address
261-1,Naka,Izunokuni,Shizuoka,Japan
TEL
055-940-3050
k-tada@dream.ocn.ne.jp
Public contact
Name of contact person
| 1st name | Kazumasa |
| Middle name | |
| Last name | Tada |
Organization
The First Yeast Co.Ltd.
Division name
Senior Managing Director
Zip code
410-2113
Address
261-1,Naka,Izunokuni,Shizuoka,Japan
TEL
055-940-3050
Homepage URL
k-tada@dream.ocn.ne.jp
Sponsor or person
Institute
The First Yeast Co.Ltd.
Institute
Department
Personal name
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
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjyuku,Tokyo
Tel
03-6704-5968
jimukyoku@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
| 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
| 2024 | Year | 05 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035609
