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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027057
Receipt No. R000031016
Scientific Title Validation study for intentional flora effects with Hydrogen Coral Powder (Pure Ash Coral)
Date of disclosure of the study information 2017/04/19
Last modified on 2017/06/15

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Basic information
Public title Validation study for intentional flora effects with Hydrogen Coral Powder (Pure Ash Coral)
Acronym Validation study for intentional flora effects with Hydrogen Coral Powder (Pure Ash Coral)
Scientific Title Validation study for intentional flora effects with Hydrogen Coral Powder (Pure Ash Coral)
Scientific Title:Acronym Validation study for intentional flora effects with Hydrogen Coral Powder (Pure Ash Coral)
Region
Japan

Condition
Condition Health adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We investigate the effect of health food "Hydrogen Coral Powder (Pure Ash Coral)" to intestinal flora in healthy adults.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Intestinal bacterial flora (0 weeks & 12 weeks)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Intake 2g of Hydrogen Coral Powderper day (1g before breakfast and 1g before dinner) for 3
months.
Examination of feces 2 weeks after intake.
Interview after 3 months after intake.
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
40 years-old <=
Age-upper limit
50 years-old >
Gender Male and Female
Key inclusion criteria Not under 20 years old when giving consent.
Critical hepatic dysfunction and/or critical renal dysfunction not to be observed at screening test.
Person who give first-person consent in writing.
Key exclusion criteria None
Target sample size 10

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koji Yano
Organization First Co.,Ltd.
Division name Director
Zip code
Address 5-7-14, Kitashinagawa, Shinagawa-ku, Tokyo
TEL 03-5475-8967
Email info@suiso1st.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Makiko Ido
Organization First Co.,Ltd.
Division name Planning Office
Zip code
Address 5-7-14, Kitashinagawa, Shinagawa-ku, Tokyo
TEL 03-5475-8967
Homepage URL
Email info@suiso1st.co.jp

Sponsor
Institute First Co.,Ltd.
Institute
Department

Funding Source
Organization First Co.,Ltd.
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
Address
Tel
Email

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 株式会社メディカルインテグレーション

Other administrative information
Date of disclosure of the study information
2017 Year 04 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
In the majority part of the subjects, an increase of beneficial bacteria's ratio (Lactobacillus bifidus and Lactic acid bacterium) was confirmed. In all subject's group showing a decrease of beneficial bacteria, an increase of opportunistic bacteria's ratio was confirmed. It suggests that the balance of whole intestinal flora's composition had been restored.
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
2016 Year 11 Month 01 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 15 Day
Last follow-up date
2017 Year 05 Month 02 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 04 Month 18 Day
Last modified on
2017 Year 06 Month 15 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031016

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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