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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038932
Receipt No. R000044396
Scientific Title Improvement effect of HBF2019-04 on human bowel in healthy subjects
Date of disclosure of the study information 2020/01/28
Last modified on 2020/01/31

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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 Preinitiation
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
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=R000044396

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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