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 verify the improvement of intestinal environment due to ingestion of the test food.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	1. Total intestinal bacterial count *1 Perform the test at 0 week and at 2 and 4 weeks after the ingestion
Key secondary outcomes	1. The Japanese version of Constipation Assessment Scale MT version (CAS-MT) *1 Answer CAS-MT at 0 week and at 2 and 4 weeks after the ingestion 2. Stool form scale *2 Answer stool form scale at 0 week and at 2 and 4 weeks after the ingestion 3. Bowel movement diary *3 Recording about the defecation every day 4. Analysis of peripheral blood {Diacron-Reactive Oxygen Metabolites (d-ROM), Bone Specific Alkaline Phosphatase (BAP)} *4 Perform the test at 0 week and 4 weeks after the ingestion 5. Stool analysis {Stool IgA, organic acids (succinic acid, lactic acid, formic acid, acetic acid, propionic acid, isobutyric acid, butyric acid, isovaleric acid, valeric acid), ammonia} *5 Analyze at 0 week and at 2 and 4 weeks after the ingestion (Stool IgA: Analyze at 0 week and 4 weeks after the ingestion)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Double blind -all involved are blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Duration: 4 weeks Test material: ALBEX Dose: Drink 10 mL twice a day Administration: To drink ALBEX with a cup of water before breakfast and dinner
Interventions/Control_2	Duration: 4 weeks Test material: Placebo Dose: Drink 10 mL twice a day Administration: To drink Placebo with a cup of water before breakfast and 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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Healthy Japanese adults 2. Persons who defecate two to five times per week
Key exclusion criteria	1. Subjects who have at least one previous medical history of malignant tumor, heart failure or myocardial infarction 2. Subjects who being treated for at least one of following diseases: cardiac arrhythmia, hepatic disorder, renal disorder, cerebrovascular disorder, rheumatism, diabetes mellitus, dyslipidemia, hypertension or other chronic diseases 3. Subjects who currently take medicines (include herbal medicines) 4. Subjects who currently take Food for Specified Health Uses, Foods with Functional Claims, yogurt, and/or bifidobacteria and lactic acid bacteria beverage, bifidobacteria and lactic acid bacteria contains food 5. Subjects who are allergic to medicines or foods related to the test materials of this trial, particularly allergic to soy 6. Subjects who currently take supplements or nutrition enrichments 7. Subjects who are pregnant, lactating, or planning to get pregnant during the trial period 8. Subjects who have enrolled into other clinical trials within the last 3 months before agreeing to participate in this trial 9. Subjects are decided as unsuitable for participating in this trial by physician for other reasons
Target sample size	60

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	B&S corporation 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 Seishin-kai Medical Association Inc, Takara Medical Clinic.

Other administrative information
Date of disclosure of the study information	2016 Year 07 Month 14 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 07 Month 11 Day
Anticipated trial start date	2016 Year 07 Month 15 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 07 Month 13 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=R000026691