UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized controlled trial for improving the enteral environment by yogurt intake in human
Title of the study (Brief title)	A trial for improving the enteral environment by yogurt intake in human
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of bihidasu plain yoghurt 450g on enterobacterial flora in human.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Enteral environment evaluation 16S metagenomic analysis total metagenomic analysis metatranscriptome analysis metabolome analysis
Key secondary outcomes	Blood test (supersensitivity CRP,whole blood serotonin,MC-FAN) Questionnaires (Likert scale) Skin test (triplesense)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	3
Purpose of intervention	Educational,Counseling,Training
Type of intervention	Food
Interventions/Control_1	Duration: 19 days 1. 5 days of eating meat only 2. Designated meal (duration: 14 days) Test material: none
Interventions/Control_2	Duration: 19 days 1. 5 days of eating meat only 2. Designated meal with BB536 intake (duration: 14 days) Test material: bifidus plain yogurt 450 g (100 g) One hundred g two times/day (200 g/day) after eating meat period
Interventions/Control_3	Duration: 19 days 1. 5 days of eating meat with BB536 2. Designated meal with BB536 intake (duration: 14 days) Test material: bifidus plain yogurt 450 g (BB536) One hundred g two times/day (200 g/day) during/after eating meat period
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	50 years-old >=
Gender	Male and Female
Key inclusion criteria	a) Healthy adults, who Japanese b) Persons who are between 20 and 50 years old c) Persons who are no resistance to eating meat (non-vegetarian) d) Persons who are stool frequency is more than 6 days per week
Key exclusion criteria	a)Persons who have previous medical history of malignant tumor or heart failure or myocardial infarction b)Patients being treated for at least one of following diseases atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, disease of digestive system and other chronic disease c)Persons who take medicines, herbal medicines d)Persons who are allergic to medicines, or products related to the test material of this trial e)Pregnant women, lactating women, or women who want to get pregnant during the trial period f)Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial g)Persons who are judged not suitable to participate in this trial by physician
Target sample size	30

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Email	kazu@orthomedico.jp

Public contact
Name of contact person	Naoko SUZUKI
Organization	ORTHOMEDICO, Inc.
Division name	R&D Department
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1 Koishikawa, Bunkyo-ku, Tokyo.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	Integrate Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Seishin-kai Medical Association Inc, Takara Medical Clinic.
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	医療法人社団 盛心会 タカラクリニック (東京都) Seishin-kai Medical Association Inc, Takara Medical Clinic (Tokyo)

Other administrative information
Date of disclosure of the study information	2014 Year 06 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 04 Month 14 Day
Anticipated trial start date	2014 Year 06 Month 02 Day
Last follow-up date	2014 Year 08 Month 01 Day
Date of closure to data entry	2014 Year 08 Month 01 Day
Date trial data considered complete	2014 Year 08 Month 01 Day
Date analysis concluded	2014 Year 08 Month 01 Day

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

Management information
Registered date	2014 Year 06 Month 04 Day
Last modified on	2017 Year 01 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016498