UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043674 |
|---|---|
| Receipt number | 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 10:27:23 |
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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
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
y-hira@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049873
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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