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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024717
Receipt No. R000028436
Scientific Title A research of intestinal environment of subjects who have ingested foods containing Bifidobacterium capsules for long term
Date of disclosure of the study information 2016/11/07
Last modified on 2018/02/22

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Basic information
Public title A research of intestinal environment of subjects who have ingested foods containing Bifidobacterium capsules for long term
Acronym A research of intestinal environment of subjects who have ingested foods containing Bifidobacterium capsules for long term
Scientific Title A research of intestinal environment of subjects who have ingested foods containing Bifidobacterium capsules for long term
Scientific Title:Acronym A research of intestinal environment of subjects who have ingested foods containing Bifidobacterium capsules for long term
Region
Japan

Condition
Condition Adults in good health
Classification by specialty
Not applicable Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To research intestinal environment of subjects who have ingested foods containing Bifidobacterium capsules for long term
Basic objectives2 Others
Basic objectives -Others Research
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 16S metagenome analysis of gut microbiota.
Metabolome analysis of intestinal metabolites.

Key secondary outcomes Questionnaire

Base
Study type Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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 when obtaining informed consent.
2) Subjects who have been ingesting foods containing Bifidobacterium capsules regularly for more than four years.
3) Subjects whose ingestion rate of foods containing Bifidobacterium capsules is more than 80%.
4) Subjects who don't ingest supplement regularly except foods containing Bifidobacterium capsules.
5) Subjects who don't take fermented foods, yogurt and/or dietary fiber foods etc. regularly, for intestinal regulation.
6) Subjects who don't use medicines on a daily basis.
7) 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 have undergone abdominal surgical operation within 6 month before the questionnaire.
2) Subjects who have taken antibiotics at least once within 6 month before the questionnaire.
3) Subjects who expect to have a big change on their lifestyle before and/or after feces sampling.
4) Subjects with tendency of chronic diarrhea.
5) Subjects considered inadequate for the current test due to their medical history of serious liver, kidney and heart disease.
6) Subjects suspected to have chronic or acute infectious disease.
7) Pregnant or possibly pregnant women, or lactating women.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yukimasa Tanaka
Organization MORISHITA JINTAN CO.,LTD.
Division name Jintan Biopharma Research Laboratory, Research & Development Division
Zip code
Address 11-1, Tsudayamate 2-Chome, Hirakata-City, Osaka,540-8566, JAPAN
TEL 072-800-1044
Email yukimasa-tanaka@jintan.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Mamiko Kohno
Organization MORISHITA JINTAN CO.,LTD.
Division name Jintan Biopharma Research Laboratory, Research & Development Division
Zip code
Address 6F Ascend-kanda Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL 03-6206-8138
Homepage URL
Email m_kohno@jintan.co.jp

Sponsor
Institute MORISHITA JINTAN CO.,LTD.
Institute
Department

Funding Source
Organization Own resources
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor MetaGen,Inc.
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
2016 Year 11 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
2016 Year 10 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 07 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Study design: Research
Subject recruitment method: Subjects will be selected from adult applicants according to selection criteria and exclusion criteria, and in consideration of the balance of their age and sex.
Measurement items:
16S metagenome analysis and metabolome analysis of fecales samples.

Management information
Registered date
2016 Year 11 Month 04 Day
Last modified on
2018 Year 02 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028436

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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