UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018924 |
|---|---|
| Receipt number | R000021894 |
| Scientific Title | The evaluation test of intestinal environmental change by intake of Bifidobacterium capsules |
| Date of disclosure of the study information | 2015/09/07 |
| Last modified on | 2017/06/07 17:22:14 |
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Basic information
Public title
The evaluation test of intestinal environmental change by intake of Bifidobacterium capsules
Acronym
The evaluation test of intestinal environmental change by intake of Bifidobacterium capsules
Scientific Title
The evaluation test of intestinal environmental change by intake of Bifidobacterium capsules
Scientific Title:Acronym
The evaluation test of intestinal environmental change by intake of Bifidobacterium capsules
Region
| Japan |
Condition
Condition
Subjects with tendency of constipation
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to investigate the effect of Bifidobacterium in enteric capsules of intestinal environmental change in adults who have constipation tendency.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improving effect of intestinal environment (bowel movement, intestinal microflora, intestinal metabolite) during 2 weeks of consumption.
Key secondary outcomes
Questionnaire of physical feeling during 2 weeks of consumption.
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
Test food : Enteric seamless capsules which contain Bifidobacterium longum JBL01, Intake duration : 2 weeks, Intake amount : 0.53 g/day -
Washout 4 weeks -
Placebo food : Enteric seamless capsules which contain no Bifidobacterium longum JBL01, Intake duration : 2 weeks, Intake amount : 0.53 g/day
Interventions/Control_2
Placebo food : Enteric seamless capsules which contain no Bifidobacterium longum JBL01, Intake duration : 2 weeks, Intake amount : 0.53 g/day -
Washout 4 weeks -
Test food : Enteric seamless capsules which contain Bifidobacterium longum JBL01, Intake duration : 2 weeks, Intake amount : 0.53 g/day
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
Male and Female
Key inclusion criteria
(1)Males and females aged 40 to 60 years old.
(2)Subjects, 75% of those defecate between 3 to 6 times in a week, 25% of those defecate 7 times and more in a week.
(3)Subjects who don't take fermented foods, dietary fibers and supplements regularly.
(4) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria
(1)Subjects who didn't undergo abdominal surgical operation within 6 month before test start.
(2)Subjects who didn't take antibiotics for 1 month or more within 6 month before test start.
(3) Subjects who have allergy to test food.
(4) Subjects who plan big change of lifestyle during test period.
(5)Subjects with tendency of chronic diarrhea.
(6)Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart.
(7)Subjects who suspected chronic or acute infectious disease.
(8)Females who are pregnant or lactating, and females who could become pregnant or lactating during test period.
(9) Subjects who participated the other clinical test within 1 month before test start.
(10) Others who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Katsuhisa Sakano |
Organization
CPCC Company Limited
Division name
Clinical Research Planning Department
Zip code
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
k.s@cpcc.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Makoto Ichinohe |
Organization
CPCC Company Limited
Division name
Plan Sales Department
Zip code
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
m.i@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
MetaGen, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
MORISHITA JINTAN Co.,LTD.
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
| 2015 | Year | 09 | Month | 07 | 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
| 2015 | Year | 08 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 09 | Month | 10 | 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
| 2015 | Year | 09 | Month | 07 | Day |
Last modified on
| 2017 | Year | 06 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021894
