UMIN-CTR Clinical Trial

Basic information
Public title	Improvement effect of HBF2019-04 on human bowel in healthy subjects
Acronym	Improvement effect of HBF2019-04 on human bowel
Scientific Title	Improvement effect of HBF2019-04 on human bowel in healthy subjects
Scientific Title:Acronym	Improvement effect of HBF2019-04 on human bowel
Region	Japan

Condition
Condition	a tendency toward constipation (healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the improvement effect of beverages containing HBF2019-04 on human constipation
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	defecation frequency, defecation days, stool output, fecal condition (week 0-week 4)
Key secondary outcomes	[Secondary outcomes] *Analysis of the intestinal flora microbiota (week 0, week 4) *Visual Analogue Scale (week 0, week 4) *Body fat percentage [Safety] Doctor's questions (week 0-week 4)

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Placebo beverage (for 4-week intake) -> 4-week washout -> Test beverage, containing HBF2019-04 (for 4-week intake)
Interventions/Control_2	Test beverage, containing HBF2019-04 (for 4-week intake) -> 4-week washout -> Placebo beverage (for 4-week intake)
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	[1] Healthy males and females aged 20-69 years old when informed consent. [2] A tendency toward constipation (at 2-5 times of defecation per week). [3] Individuals giving written informed consent.
Key exclusion criteria	[1] Who have a disease and/or surgical history of serious hepatopathy, kidney damage, gastrointestinal disease, heart disease, peripheral vascular disorder, others which may affect the results of the study. [2] Who with liver disorder, and/or kidney disorder. [3] who are under medical treatments. [4] Who are allergic to foods and/or medicines. [5] Who are diagnosed as anemia. [6] Who play intense sports and/or on a diet. [7] Who use supplements which may affect the results of the study. [8] Who daily intake fermented foods such as yogurt and natto. [9] Who take medicines. [10] Who daily take excessive alcohol, and/or can't abstinent from alcohol from the day before the each examinations. [11] Who donated blood over 200 mL as a component blood or whole blood from 4 weeks before the start of this study. [12] Who are or are possibly pregnant, or who are lactating, during the study period. [13] Who are participating or are willing to participate in other studies. [14] Who are judged inappropriate for the study by the investigator.
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Naoki Middle name Last name Miura
Organization	Miura Clinic, Medical Corporation Kanonkai
Division name	Internal Medicine
Zip code	530-0044
Address	Higashitenma Bldg. 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
TEL	06-6135-5200
Email	info@miula.co.jp

Public contact
Name of contact person	1st name Yuki Middle name Last name Ishida
Organization	Hayashibara CO., LTD.
Division name	R & D Division, Development Unit
Zip code	702-8006
Address	675-1, Fujisaki, Naka-ku, Okayama
TEL	086-276-3141
Homepage URL
Email	yuki.ishida@hb.nagase.co.jp

Sponsor
Institute	Oneness Support Co., Ltd.
Institute
Department

Funding Source
Organization	Hayashibara 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	The Ethics Committee of Miura Clinic, Medical Corporation Kanonkai
Address	Higashitenma Bldg. 9F, 1-7-17, Higashitenma, Kita-ku, Osaka, Osaka
Tel	06-6135-5200
Email	mterashima@miura-cl.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	医療法人花音会みうらクリニック（大阪府） / Miura Clinic, Medical Corporation Kanonkai (Osaka)

Other administrative information
Date of disclosure of the study information	2020 Year 01 Month 28 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	2019 Year 11 Month 21 Day
Date of IRB	2019 Year 11 Month 22 Day
Anticipated trial start date	2020 Year 01 Month 28 Day
Last follow-up date	2020 Year 04 Month 30 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 12 Month 19 Day
Last modified on	2022 Year 01 Month 24 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000044396