UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028826 |
|---|---|
| Receipt number | 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 08:34:35 |
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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
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
ochitani@huma-c.co.jp
Sponsor or person
Institute
HUMA R&D CORP
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032990
