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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028826
Receipt No. R000032990
Scientific Title Examination of an influence of inulin intake on functions of the intestines.
Date of disclosure of the study information 2017/09/20
Last modified on 2018/03/01

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Basic information
Public title Examination of an influence of inulin intake on functions of the intestines.
Acronym Examination of an influence of inulin intake on functions of the intestines.
Scientific Title Examination of an influence of inulin intake on functions of the intestines.
Scientific Title:Acronym 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
1st name
Middle name
Last name Toya Hidemasa
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
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
1st name
Middle name
Last name Ochitani Daisuke
Organization HUMA R&D CORP
Division name Clinical Development Division
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 07 Month 14 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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