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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000029253
Receipt No. R000033434
Scientific Title A confirmation study for improving effects of probiotics and synbiotics on intestinal environment in healthy adults.
Date of disclosure of the study information 2019/04/01
Last modified on 2019/06/06

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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 Not applicable

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
Middle name
Last name Yoshitaka Iwama
Organization Nihonbashi Cardiology Clinic
Division name Director
Zip code
Address 13-4 Nihonbashikodenma-cho, Chuo-ku, Tokyo, Japan
TEL +81-3-5641-4133
Email yiwama@well-sleep.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eiji Yoshikawa
Organization KSO Co., Ltd
Division name Sales Corporation
Zip code
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
Address
Tel
Email

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 医療法人財団健康睡眠会 日本橋循環器科クリニック

Other administrative information
Date of disclosure of the study information
2019 Year 04 Month 01 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 Terminated
Date of protocol fixation
2017 Year 09 Month 14 Day
Date of IRB
2017 Year 09 Month 14 Day
Anticipated trial start date
2017 Year 09 Month 24 Day
Last follow-up date
2017 Year 12 Month 03 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 09 Month 22 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=R000033434

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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