UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Validation study for intentional flora effects with Hydrogen Coral Powder (Pure Ash Coral)
Title of the study (Brief title)	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	Koji Yano
Organization	First Co.,Ltd.
Division name	Director
Address	5-7-14, Kitashinagawa, Shinagawa-ku, Tokyo
TEL	03-5475-8967
Email	info@suiso1st.co.jp

Public contact
Name of contact person	Makiko Ido
Organization	First Co.,Ltd.
Division name	Planning Office
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 11 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
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.
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