UMIN-CTR Clinical Trial

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

a tendency toward constipation (healthy adults)

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO

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

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)

Study type

Interventional

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

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

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

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

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

Institute

Oneness Support Co., Ltd.

Institute

Department

Personal name

Organization

Hayashibara CO., LTD.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2020

Year

01

Month

28

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

Registered date

2019

Year

12

Month

19

Day

Last modified on

2022

Year

01

Month

24

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044396