UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A research of intestinal environment of subjects who have ingested foods containing Bifidobacterium capsules for long term
Title of the study (Brief title)	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	Yukimasa Tanaka
Organization	MORISHITA JINTAN CO.,LTD.
Division name	Jintan Biopharma Research Laboratory, Research & Development Division
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	Mamiko Kohno
Organization	MORISHITA JINTAN CO.,LTD.
Division name	Jintan Biopharma Research Laboratory, Research & Development Division
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 10 Month 20 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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