UMIN-CTR Clinical Trial

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

Adults in good health

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

16S metagenome analysis of gut microbiota.
Metabolome analysis of intestinal metabolites.

Key secondary outcomes

Questionnaire

Study type

Others,meta-analysis etc

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

MORISHITA JINTAN CO.,LTD.

Institute

Department

Personal name

Organization

Own resources

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

MetaGen,Inc.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2016

Year

11

Month

07

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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.

Registered date

2016

Year

11

Month

04

Day

Last modified on

2018

Year

02

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028436