UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A randomized double-blind placebo-controlled trial for improving the intestinal environment in human
Title of the study (Brief title)	A trial for improving the intestinal environment 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 "Powder of the Fermented Extract from Plants EX" on the intestinal environment in human
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 Bifidobacterium Lactobacillales Bacteroides Prevotella Clostridium cluster IV Clostridium subcluster XIVa Clostridium cluster XI Clostridium cluster XVIII Others
Key secondary outcomes	Subjective symptom CAS-MT The faecal form scale

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: 4 weeks Test material: "Powder of the Fermented Extract from Plants EX" capsules Dose: One packet (1.2g)/day Usage: ingestion of test material along with the water just after dinner
Interventions/Control_2	Duration: 4 weeks Test material: Placebo Dose: One packet (1.2g)/day Usage: ingestion of test material along with the water just 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	20 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	a) Japanese healthy adults who are between 20 and 59 years old. b) Persons whose stool frequencies are between 2 and 5 times per 7 days
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 and other chronic disease c) Persons who take medicines, herbal medicines, or supplement. d) Persons who are allergic to medicines, or products related to the test material of this trial e) Persons who habitually take foods that seem to be influential on intestinal environment, e.g., FOSHU, yogurt, and lactic fermenting beverage f) Persons who smoke g) Pregnant women, lactating women, or women who want to get pregnant during the trial period h) Persons who have been enrolled in the other clinical trials within last 3 months before the agreement for the participation to this trial i) Persons who are judged unsuitable to participate in this trial by physician
Target sample size	20

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	R&D Department
Address	25F M&D Tower, Tokyo Medical and Dental University, 1-5-45 Yushima, 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	YAGUMO KOUSAN 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

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 06 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 01 Month 14 Day
Anticipated trial start date	2015 Year 02 Month 09 Day
Last follow-up date	2015 Year 05 Month 31 Day
Date of closure to data entry	2015 Year 06 Month 19 Day
Date trial data considered complete	2015 Year 06 Month 22 Day
Date analysis concluded	2015 Year 06 Month 26 Day

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

Management information
Registered date	2015 Year 02 Month 06 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=R000019122