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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000031367
Receipt No. R000035820
Scientific Title Effect of synbiotics on intestinal environment in healthy adults.
Date of disclosure of the study information 2019/04/30
Last modified on 2018/11/14

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Basic information
Public title Effect of synbiotics on intestinal environment in healthy adults.
Acronym Effect of synbiotics on intestinal environment.
Scientific Title Effect of synbiotics on intestinal environment in healthy adults.
Scientific Title:Acronym Effect of 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 dietary fiber on intestinal environment
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Quantification of fecal bifidobacteria using quantitative real-time polymerase chain reaction
Key secondary outcomes 16S rRNA gene based metagenome analysis of gut microbiome

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 Prevention
Type of intervention
Food
Interventions/Control_1 Intake of yogurt containing bifidobacterium (concentration of 1 X 10^10 CFU) with inulin (2g) for 2 weeks - Washout 2 weeks, followed by intake of yogurt containing bifidobacterium (concentration of 1 X 10^10 CFU) with dextrin (2g) for 2 weeks
Interventions/Control_2 Intake of yogurt containing bifidobacterium (concentration of 1 X 10^10 CFU) with dextrin (2g) for 2 weeks - Washout 2 weeks, followed by intake of yogurt containing bifidobacterium (concentration of 1 X 10^10 CFU) with inulin (2g) for 2 weeks
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
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 took in food containing and bifidobacteria, and/or enhanced with oligosaccharide, dietary fiber during one week prior to the start of this study and can't stop intake during this study.
4. Subjects who change their life styles during this clinical trial
5. Subjects who have serious diseases requiring an urgent treatment, or who accept severe complication.
6. Subjects who have a medical history of diseases or surgeries affecting digestion, absorption and bowel movement.
7. Subjects who have allergy to test food.
8. Subjects who is pregnant or willing to be pregnant or breast-feeding during this study.
9. Subjects who are participated in other clinical trials that intake/apply any of food, drug, and cosmetics.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Mawatari
Organization Ezaki Glico Co., Ltd
Division name Institute of health science
Zip code
Address 4-6-5 Utajima Nishiyodogawa-ku Osaka, 555-8502, Japan
TEL +81-6-6477-8425
Email mawatari-takashi@glico.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Mawatari
Organization Ezaki Glico Co., Ltd
Division name Institute of health science
Zip code
Address 4-6-5 Utajima Nishiyodogawa-ku Osaka, 555-8502, Japan
TEL +81-6-6477-8425
Homepage URL
Email mawatari-takashi@glico.co.jp

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
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

Other administrative information
Date of disclosure of the study information
2019 Year 04 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
The number of total bifidobacteria in feces was significantly increased during the probiotic and synbiotic intake periods compared with the observation period.
There was no difference in the number of total bifidobacteria between the synbiotic intake period and the probiotic intake period (The average number of total bifidobacteria was higher in the symbiotic intake period compared to the probiotic intake period.). Moreover, the number of endogenous bifidobacteria was significantly higher in the synbiotic intake period compared to the probiotic intake period.
By stratified analysis according to the number of B. lactis in the probiotic intake period (less than 5 X 10^9 cells/g), the number of total bifidobacteria, endogenous bifidobacteria and B. lactis was significantly higher in the symbiotic intake period compared to the probiotic intake period.
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
2018 Year 02 Month 19 Day
Date of IRB
Anticipated trial start date
2018 Year 02 Month 19 Day
Last follow-up date
2018 Year 04 Month 12 Day
Date of closure to data entry
2018 Year 05 Month 05 Day
Date trial data considered complete
2018 Year 05 Month 09 Day
Date analysis concluded
2018 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2018 Year 02 Month 19 Day
Last modified on
2018 Year 11 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035820

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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