UMIN-CTR Clinical Trial

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
Email	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
Email	tsuyoshi.sadakiyo@hb.nagase.co.jp

Sponsor
Institute	Hayashibara Co., Ltd.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042286