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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000029088
Receipt No. R000033268
Scientific Title Effect of probiotics and/or synbiotics on intestinal environment in healthy adults.
Date of disclosure of the study information 2019/04/01
Last modified on 2019/09/06

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Basic information
Public title Effect of probiotics and/or synbiotics on intestinal environment in healthy adults.
Acronym Effect of probiotics and/or synbiotics on intestinal environment.
Scientific Title Effect of probiotics and/or synbiotics on intestinal environment in healthy adults.
Scientific Title:Acronym Effect of probiotics and/or synbiotics on intestinal environment.
Region
Japan

Condition
Condition Healthy adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To verify the effect of bifidobacterium and/or bifidobacterium with dietary fiber on intestinal environment.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes 16S rRNA gene based metagenome analysis of gut microbiome
Key secondary outcomes Fecal short chain fatty acid concentration, fecal bifidobacteria, defecation frequency

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Active
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 drink containing high-dose bifidobacterium for 4 weeks - Washout 4 weeks.
Interventions/Control_2 Intake of drink containing low-dose bifidobacterium for 4 weeks - Washout 4 weeks.
Interventions/Control_3 Intake of drink containing bifidobacterium with dietary fiber for 4 weeks - Washout 4 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 Subjects whose defecation frequency is more than five times per week.
Key exclusion criteria 1. Subjects regularly use intestinal drugs and laxatives (including strong laxatives).
2. Subjects habitually consume higher amount of alcohol.
3. Subjects who can't stop intake food containing bifidobacteria, and/or enhanced with oligosaccharide, dietary fiber during this study.
4. Subjects who have serious diseases requiring an urgent treatment, or who accept severe complication.
5. Subjects who have a medical history of diseases or surgeries affecting digestion, absorption and bowel movement.
6. Subjects who have allergy to test food.
7. Subjects who is pregnant or willing to be pregnant or breast-feeding during this study.
8. Subjects who are participated in other clinical trials that intake/apply any of food, drug, and cosmetics.
Target sample size 45

Research contact person
Name of lead principal investigator
1st name Takashi
Middle name
Last name Mawatari
Organization Ezaki Glico Co., Ltd
Division name Institute of health science
Zip code 555-8502
Address 4-6-5 Utajima Nishiyodogawa-ku Osaka, 555-8502, Japan
TEL 0664778425
Email takashi.mawatari@glico.com

Public contact
Name of contact person
1st name Takashi
Middle name
Last name Mawatari
Organization Ezaki Glico Co., Ltd
Division name Institute of health sciences
Zip code 555-8502
Address 4-6-5 Utajima Nishiyodogawa-ku Osaka, 555-8502, Japan
TEL 0664778425
Homepage URL
Email takashi.mawatari@glico.com

Sponsor
Institute Ezaki Glico Co., Ltd
Institute
Department

Funding Source
Organization Ezaki Glico Co., Ltd
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization The Institutional Review Board of Glico Group
Address 2-4, Komatsubara-cho, Kita-ku, Osaka, Japan
Tel +81-6-6477-8201
Email ebisutani-kazuki@glico.co.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 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 63
Results
1. The intestinal microbiota is modulated.
2. The Faecalibacterium ratio, Bifidobacterium ratio and number, as well as the amount of short-chain fatty acid in feces increase.
3. The effect on intestinal microbiota varies depending on the number of ingested bacteria.
Results date posted
2019 Year 09 Month 06 Day
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 09 Month 04 Day
Date of IRB
2017 Year 09 Month 04 Day
Anticipated trial start date
2017 Year 09 Month 11 Day
Last follow-up date
2017 Year 12 Month 08 Day
Date of closure to data entry
2019 Year 03 Month 04 Day
Date trial data considered complete
2019 Year 03 Month 06 Day
Date analysis concluded
2019 Year 03 Month 31 Day

Other
Other related information The group of interventions control 3 was excluded from analysis due to defect of the test drink.

Management information
Registered date
2017 Year 09 Month 11 Day
Last modified on
2019 Year 09 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033268

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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