UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Prospective intervention study for antimicrobial effect of Agaricus bisporus agglutinin as functional food.
Title of the study (Brief title)	Prospective intervention study for antimicrobial effect of Agaricus bisporus agglutinin as functional food.
Region	Japan

Condition
Condition	Periodontitis
Classification by specialty	Dental medicine
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to investigate for antimicrobial effect of Agaricus bisporus agglutinin as functional food with prospective intervention study .
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	bacterial count on tooth surface
Key secondary outcomes

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	food with ABA
Interventions/Control_2	food without ABA
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	20 years of age or older of the university faculties, graduate students or research students. A person the procedure of the informed consent has been completed, never forced.
Key exclusion criteria	the exclusion criteria are allergic to mushroom, and pregnant or lactating.
Target sample size	20

Research contact person
Name of lead principal investigator	Shogo Tahashiba
Organization	Okayama University Graduate School of Medicine, Dentistry and Pharmaceutical Sciences Biopathological Science
Division name	Department of Pathophysiology - Periodontal Science
Address	2-5-1 Shikata-cho, Kita-ku, Okayama 700-8525, Japan
TEL	086-235-6677
Email	shotakashi@gmail.com

Public contact
Name of contact person	Takashi Ito
Organization	Okayama University Hospital
Division name	Center for innovation clinical medicine
Address	2-5-1 Shikata-cho, Kita-ku, Okayama
TEL	086-235-6677
Homepage URL
Email	gmd19073@s.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	MEXT(Japan)
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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

Other administrative information
Date of disclosure of the study information	2016 Year 03 Month 31 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 02 Month 16 Day
Anticipated trial start date	2016 Year 02 Month 23 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 03 Month 31 Day
Last modified on	2016 Year 03 Month 31 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-bin/ctr_e/ctr_view.cgi?recptno=R000024850