UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The evaluation test of intestinal environmental change by intake of Bifidobacterium capsules
Title of the study (Brief title)	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	Katsuhisa Sakano
Organization	CPCC Company Limited
Division name	Clinical Research Planning Department
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	Makoto Ichinohe
Organization	CPCC Company Limited
Division name	Plan Sales Department
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 08 Month 18 Day
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

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Publication of results	Unpublished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