UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Validation study for intestinal functions and anti-inflammatory effect in heathy Japanese adults: a double-blind randomized controlled trial
Title of the study (Brief title)	Validation study for intestinal functions and anti-inflammatry effect in heathy Japanese adults
Region	Japan

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

Objectives
Narrative objectives1	We investigate the effect of "Enterococcus faecalis KH2" on intestinal bacterial flora and inflammation in persons with slight constipation.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Intestinal bacterial flora
Key secondary outcomes	CAS-MT Bristol stool scale High sensitivity CRP

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	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 1 week Test food: Enterococcus faecalis KH2 strain supplement Dose: once a day (1 pack/day) Usage: ingestion of test food along with the water or hot water after dinner
Interventions/Control_2	Duration: 1 week Test food: placebo Dose: once a day (1 pack/day) Usage: ingestion of test food along with the water or hot water after dinner
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	30 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adults 2. Defecation (2~5 times/week) 3. Persons who are between 30 and 59 years old
Key exclusion criteria	1. At least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Currently under treatment for either atrial fibrillation, cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension, disease of digestive system (including ulcerative colitis, gastric ulcer, Diverticular Disease of the Colon, etc) or other chronic disease 3. Currently taking medicines, herbal medicines 4. Usually taking yogurt, oligosaccharide or lactic acid bacteria. 5. Allergic to medicines or foods related to the test food of this trial 6. Usually taking supplements and nutrient function foods 7. Pregnant, lactating, or planning to get pregnant during the trial period 8. Enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 9. Judged unsuitable for participating 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	Specified Nonprofit Corporation The Japanese Association of Clinical Research on Supplements
Organization
Division
Category of Funding Organization	Other
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	2015 Year 06 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 06 Month 02 Day
Anticipated trial start date	2015 Year 06 Month 04 Day
Last follow-up date	2015 Year 08 Month 28 Day
Date of closure to data entry	2015 Year 08 Month 28 Day
Date trial data considered complete	2015 Year 08 Month 28 Day
Date analysis concluded	2015 Year 08 Month 28 Day

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

Management information
Registered date	2015 Year 06 Month 03 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=R000020616