UMIN-CTR Clinical Trial

Basic information
Public title	A confirmation study for improving effects of probiotics and synbiotics on intestinal environment in healthy adults.
Acronym	A confirmation study for improving effects of probiotics and synbiotics on intestinal environment.
Scientific Title	A confirmation study for improving effects of probiotics and synbiotics on intestinal environment in healthy adults.
Scientific Title:Acronym	A confirmation study for improving effects of probiotics and synbiotics on intestinal environment.
Region	Japan

Condition
Condition	Subjects with a tendency for constipation
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To examine the effect of bifidobacterium GCL2505 and bifidobacterium GCL2505 with inulin on gut bifidobacteria and intestinal environment of subjects with a tendency for constipation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	fecal bifidobacteria
Key secondary outcomes	defecation days, defecation frequency

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	3
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Intake of test drink containing bifidobacterium GCL2505 (concentration of 1 X 10^10 CFU) for 2 weeks - Washout 2 weeks.
Interventions/Control_2	Intake of test drink containing bifidobacterium GCL2505 (concentration of 1 X 10^10 CFU) and inulin (2g) for 2 weeks - Washout 2 weeks.
Interventions/Control_3	Intake of placebo drink (not containing bifidobacterium GCL2505 and inulin) for 2 weeks - Washout 2 weeks.
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	20 years-old <=
Age-upper limit	65 years-old >
Gender	Male and Female
Key inclusion criteria	1. Subjects whose defecation frequency is no fewer than 2, nor more than 5. 2. Subjects who usually have three meals a day.
Key exclusion criteria	1. Subjects who regularly use intestinal drugs and laxatives (including strong laxatives). 2. Subjects who regularly intake healthy food to relieve constipation. 3. Subjects who use medicine such as antibiotics that affect digestion and absorption. 4. Subjects who can't stop intake food containing viable bacteria such as Lactic acid bacteria, Bifidobacteria, Natto bacteria and/or enhanced with oligosaccharide, dietary fiber and/or the health food to relieve constipation (including Food for Specified Health Uses (FOSHU)) and/or containing a large amount of sugar alcohol during this study. 5. Subjects who have allergic to food. 6. Subjects who have serious diseases requiring an urgent treatment, or who accept severe complication. 7. Subjects who has a medical history of diseases or surgeries affecting digestion, absorption and bowel movement. 8. Subjects are judged unsuitable for this study based on subject questionnaire. 9. Subjects who is pregnant or willing to be pregnant or breast-feeding during this study 10. Subjects who has a current or history of drug dependence and/or alcoholism. 11. Subjects who are participated in other clinical trials that intake/apply any of food, drug, and cosmetics, or willing to be that 12. Subjects who are judged unsuitable for this study by principal investigator
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Satoru Middle name Last name Suzuki
Organization	Shinagawa Season Terrace Health Care Clinic
Division name	Medical examination and treatment management family chief director
Zip code	108-0075
Address	1-2-70, Konan, Minato-ku, Tokyo, Japan
TEL	+81-3-3452-3381
Email	satoru_suzuki@sempos.or.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Yoshikawa
Organization	KSO Co., Ltd
Division name	Sales department
Zip code	105-0023
Address	1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL	+81-3-3542-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Co., Ltd
Institute
Department

Funding Source
Organization	Ezaki Glico Co., Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of Shinagawa Season Terrace Health Care Clinic
Address	1-2-70, Konan, Minato-ku, Tokyo, Japan
Tel	+81-3-3452-3381
Email	tomohiro_kogo@sempos.or.jp

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	2019 Year 06 Month 30 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	2017 Year 12 Month 22 Day
Date of IRB	2017 Year 12 Month 22 Day
Anticipated trial start date	2018 Year 02 Month 04 Day
Last follow-up date	2018 Year 05 Month 07 Day
Date of closure to data entry	2018 Year 06 Month 26 Day
Date trial data considered complete	2018 Year 07 Month 11 Day
Date analysis concluded	2018 Year 07 Month 30 Day

Other
Other related information

Management information
Registered date	2018 Year 02 Month 01 Day
Last modified on	2019 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035513