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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018924
Receipt No. 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

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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
Email 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
Email m.i@cpcc.co.jp

Sponsor
Institute CPCC Company Limited
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021894

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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