UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of an influence of inulin intake on functions of the intestines.
Title of the study (Brief title)	Examination of an influence of inulin intake on functions of the intestines.
Region	Japan

Condition
Condition	Subjects with a tendency of constipation.
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of a test food product on bowel habits by selecting males and females with a tendency of constipation as subjects and assigning them to take the test food product on a continuous basis.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase

Assessment
Primary outcomes	Intestinal flora
Key secondary outcomes	A survey on stool properties

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	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of the placebo for a week. Four-week intake of the test food product. Wash out. Intake of the placebo for a week. Four-week intake of the placebo.
Interventions/Control_2	Intake of the placebo for a week. Four-week intake of the placeb. Wash out. Intake of the placebo for a week. Four-week intake of the test food product.
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	1.Subjects giving written informed consent. 2.Age: Males and females with Japanese nationality aged 20 and over, below 60. 3.Stool frequency: 4 times/week or less.
Key exclusion criteria	1.Regular intake of lactobacillus beverage or yogurt (at least once a week) Persons who can refrain from the intake of yogurt during the study will not be excluded. 2.Currently in treatment with medication or in kinesiotherapy or diet therapy under direction of a doctor. 3.Presence of cardiovascular, hepatic, or renal disorder. 4.Participation in another clinical trial on humans within the last three months or current participation in another clinical trial on humans. 5.Previous history of hepatic disorder or severe disorder related to kidney, endocrine, cardiovascular system, gastro-intestine, lung, blood, or metabolism, or currently presence of complications. 6.Pregnant or nursing, or desired to become pregnant during the study (females only). 7.Irregular work hours such as working on night shift. 8.Presence or previous history of mental disorder (depression, etc.) 9.Currently in treatment or previous history of drug dependence or drug abuse. 10.Current intake of a health food product or supplements with a possible effect on functions of the intestines. 11.Determined by the investigator to be unsuitable for enrollment in this study.
Target sample size	30

Research contact person
Name of lead principal investigator	Toya Hidemasa
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Email	ochitani@huma-c.co.jp

Public contact
Name of contact person	Ochitani Daisuke
Organization	HUMA R&D CORP
Division name	Clinical Development Division
Address	Oekkusu Bldg10F 5-31-19 Shiba Minato-ku Tokyo 108-0014 Japan
TEL	81-3-3431-1260
Homepage URL
Email	ochitani@huma-c.co.jp

Sponsor
Institute	HUMA R&D CORP
Institute
Department

Funding Source
Organization	Fuji Nihon Seito Corporation
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 20 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 14 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 25 Day
Last modified on	2018 Year 03 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032990