UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027057 |
|---|---|
| Receipt number | 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 20:20:43 |
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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
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
info@suiso1st.co.jp
Sponsor or person
Institute
First Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
