UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of a Test Food for Defecation Improvement and Intestinal Flora
Title of the study (Brief title)	Effects of a Test Food for Defecation Improvement and Intestinal Flora
Region	Japan

Condition
Condition	N/A(healthy adults)
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This study aims to evaluate effects of a test food for defecation improvement and intestinal flora.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	[1]Indexes for evaluating defecation and intestinal flora (The Japanese Version of the Constipation Assessment Scale [middle term] [first observation: Week 0, 2, 4; second observation: Week 0, 2, 4], Bristol stool scale [first observation: Week 0, 2, 4; second observation: Week 0, 2, 4], fecal examination [analysis of intestinal flora, short-chain fatty acid, pH, putrefaction products, IgA] [[first observation: Week 0, 2, 4; second observation: Week 0, 2, 4])
Key secondary outcomes	*Secondary outcome [1]Bowel diary (from the first day of ingestion of a test material to the last day of the test) *Safety evaluation [1]Blood pressure, pulsation (Screening, First observation: Week 4, Second observation: Week 4) [2]Weight, body fat percentage, BMI (Screening, First observation: Week 4, Second observation: Week 4) [3]Doctor's questions (Screening, First observation: Week 4, Second observation: Week 4) [4]Subject's diary(from the first day of ingestion of a test material to the last day of the test)

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	[1]Oral ingestion of the test food (2 tablets once a day for 4 weeks) [2]Washout (4 week) [3]Oral ingestion of the placebo food (2 tablets once a day for 4 weeks)
Interventions/Control_2	[1]Oral ingestion of the Placebo food (2 tablets once a day for 4 weeks) [2]Washout (4 week) [3]Oral ingestion of the test food (2 tablets once a day for 4 weeks)
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	40 years-old <=
Age-upper limit	60 years-old >=
Gender	Female
Key inclusion criteria	[1]Japanese females aged 40-60 years. [2]Individuals who are healthy and are not suffered from a chronic malady. [3]Individuals with a tendency for constipation (at 3-4 times of defecation per week). [4]Individuals whose written informed consent has been obtained. [5]Individuals judged appropriate for the study by the principal.
Key exclusion criteria	[1]Individuals who have a habit of intaking a food containing lactic acid bacteria powder over 4 times per week. [2]Individuals using medical products. [3]Individuals who have a habit of using or applying a drug. [4]Individuals who intake laxatives, antiflatulent, or supplements aiming to improve bowel movements (ex. indigestible dextrin, oligosaccharide, dietary fiber-rich foods). [5]Individuals whose dietary pattern is unstable. [6]Individuals who take medicine in the past 1 month to remedy disease (except of temporal taking medicine for headache or cold). [7]Individuals who intook antibiotics in the past 1 month. [8]Individuals who have a history of heart failure, kidney failure, hepatitis B or hepatitis C. [9]Individuals who are a patient or have a history of or endocrine disease. [10]Individuals whose BMI is over 25 kg/m2. [11]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 60g/day). [12]Individuals who are a smoker. [13]Individuals with serious anemia. [14]Individuals who are sensitive to test product or other foods, and medical products. [15]Individuals who had a habit to ingest health-promoting foods, foods for specified health uses, health foods, or supplements in the past 3 months or will ingest those foods during the test period. [16]Individuals whose life style will be changed during the test period. [17]Individuals who have a habit to use drug claiming to improve skin condition in the past 3 months. [18]Individuals who cannot collect fecal samples in their own house and submit them to the designated organization. [19]Individuals who are or whose family is engaged in healthy or functional foods. [20]Individuals judged inappropriate for the study by the principal.
Target sample size	12

Research contact person
Name of lead principal investigator	Shuji Nakata
Organization	Medical Corporation Bokushinkai CLINTEXE Clinic
Division name	Head
Address	4F Atago Green Hills Mori Tower 2-5-1 Atago Minato-ku Tokyo 105-6204, JAPAN
TEL	03-5405-1059
Email	info@tes-h.co.jp

Public contact
Name of contact person	Ryoma Shimizu
Organization	TES Holdings Co., Ltd
Division name	Administrative Department of Clinical Trials
Address	6F University of Tokyo Entrepreneur Plaza 7-3-1 Hongo Bunkyo-ku Tokyo 113-0033, JAPAN
TEL	03-6801-8480
Homepage URL
Email	r.shimizu@tes-h.co.jp

Sponsor
Institute	TES Holdings Co., Ltd
Institute
Department

Funding Source
Organization	TAKARA BIO INC.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	2017 Year 09 Month 21 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 08 Month 25 Day
Anticipated trial start date	2017 Year 09 Month 21 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 09 Month 21 Day
Last modified on	2018 Year 03 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033264