UMIN-CTR Clinical Trial

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

Subjects with tendency of constipation

Classification by specialty

Not applicable

Adult

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

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

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

Institute

CPCC Company Limited

Institute

Department

Personal name

Organization

MetaGen, Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

MORISHITA JINTAN Co.,LTD.

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

2015

Year

09

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

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 related 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