UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The verification study for improving the intestinal environment: A randomized open-label parallel-group study
Title of the study (Brief title)	The verification study for improving the intestinal environment
Region	Japan

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

Objectives
Narrative objectives1	To verify the effects of the test food on improving intestinal environment
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) * Assess at screening and examination before consuming, and at 1, 2, 3, and 4 weeks after consuming
Key secondary outcomes	1. Bacterial flora analysis (Terminal Restriction Fragment Length Polymorphism; T-RFLP) 2. Subjective symptoms a. Bowel movement diary b. Bristol scale *1 Assess at 0 and 4 weeks after consuming *2 Record the diary from a week before consuming to the day before 4 weeks after consuming

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Dose comparison
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 materials: Fermented plant extracts Dose: 3 packs per day (2 g x 3) Administration: Take 1 pack of the test food after breakfast, lunch, and dinner. *If you forget to take the test food, take it as soon as you remember within the day.
Interventions/Control_2	Duration: 4 weeks Test materials: Fermented plant extracts Dose: 1 pack (2 g) per day Administration: Take 1 pack of the test food after breakfast. *If you forget to take the test food, take it as soon as you remember within the day.
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	50 years-old >
Gender	Female
Key inclusion criteria	1. Healthy Japanese females 2. Subjects who defecate two to five times per week 3. Subjects who are judged as eligible to participate in the study by the principal investigator 4. Subjects who have relatively high CAS score in the Japanese version of CAS-MT at screening and examination before consuming
Key exclusion criteria	1. At least one previous medical history or under the treatment of malignant tumor, heart failure or myocardial infarction 2. Currently under the treatment for either cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Subjects who use or take "Foods for Specified Health Uses", "Foods with Functional Claims", food/beverage including lactic acid bacteria, or other functional food/beverage in daily 4. Currently taking medicines (include herbal medicines) and supplements 5. Subjects who are allergic to medicines and/or the test food related products 6. Subjects who are allergic to latex 7. Subjects who are pregnant, breast-feeding, and plan to become a pregnant 8. Subjects who have been enrolled in other clinical trials within the last three months before the agreement to participate in this trial 9. Subjects who are judged as ineligible to participate in the study by the principal investigator
Target sample size	14

Research contact person
Name of lead principal investigator	Kazuo YAMAMOTO
Organization	ORTHOMEDICO Inc.
Division name	CEO
Address	2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan.
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, Japan.
TEL	03-3818-0610
Homepage URL
Email	nao@orthomedico.jp

Sponsor
Institute	ORTHOMEDICO Inc.
Institute
Department

Funding Source
Organization	Functional Food Creation Research Institute Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Medical Corporation Seishinkai, Takara 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) Medical Corporation Seishinkai, Takara Medical Clinic (Tokyo, Japan)

Other administrative information
Date of disclosure of the study information	2017 Year 08 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 07 Day
Anticipated trial start date	2017 Year 08 Month 18 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	2017 Year 08 Month 09 Day
Last modified on	2018 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032742