UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037115 |
|---|---|
| Receipt number | R000042286 |
| Scientific Title | Assessment on no observed adverse effect level of the test food (HBF2019-01) for loose stools |
| Date of disclosure of the study information | 2019/06/24 |
| Last modified on | 2020/01/31 14:54:12 |
* 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
Assessment on no observed adverse effect level of the test food (HBF2019-01) for loose stools
Acronym
Assessment on no observed adverse effect level of the test food for loose stools
Scientific Title
Assessment on no observed adverse effect level of the test food (HBF2019-01) for loose stools
Scientific Title:Acronym
Assessment on no observed adverse effect level of the test food for loose stools
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate no observed adverse effect level of the test food for loose stools
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Stool form
Key secondary outcomes
Abdominal symptoms
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
Stepwise feeding of test food
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) Healthy adults who had at least 3 defecations per week
2) Employees at the Hayashibara CO., LTD.
3) Subjects who agree to sign the informed consent for participation in the study
4) Subjects who may cause loose stools besides feeding of the test food
Key exclusion criteria
1) Underage
2) Women who are pregnant or may be pregnant
3) Subjects who may affect the result of the study due to the medications
4) Subjects who are judged to have loose stools or constipation on a daily basis
5) Subjects who cannot attend the designated time and place
6) Subjects who judged as unsuitable for this study by the principal physician investigator
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Sadakiyo |
Organization
Hayashibara Co., Ltd.
Division name
Development Unit, R&D Division
Zip code
702-8006
Address
675-1, Fujisaki, Naka-ku, Okayama, Japan
TEL
086-276-3141
tsuyoshi.sadakiyo@hb.nagase.co.jp
Public contact
Name of contact person
| 1st name | Tsuyoshi |
| Middle name | |
| Last name | Sadakiyo |
Organization
Hayashibara Co., Ltd.
Division name
Development Unit, R&D Division
Zip code
702-8006
Address
675-1, Fujisaki, Naka-ku, Okayama, Japan
TEL
086-276-3141
Homepage URL
tsuyoshi.sadakiyo@hb.nagase.co.jp
Sponsor or person
Institute
Hayashibara Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
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
The Ethics Committee of Hayashibara Co., Ltd.
Address
675-1, Fujisaki, Naka-ku, Okayama, Japan
Tel
086-276-3141
HB96301@hb.nagase.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
株式会社林原（岡山県） / Hayashibara Co., Ltd. (Okayama)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 06 | Month | 24 | 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
| 2019 | Year | 05 | Month | 13 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2019 | Year | 07 | 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
| 2019 | Year | 06 | Month | 19 | Day |
Last modified on
| 2020 | Year | 01 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042286
