UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000031367 |
|---|---|
| Receipt number | 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 11:21:53 |
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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
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
mawatari-takashi@glico.co.jp
Sponsor or person
Institute
Ezaki Glico Co., Ltd
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035820
