UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029088 |
|---|---|
| Receipt number | 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 16:23:47 |
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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
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
takashi.mawatari@glico.com
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
The Institutional Review Board of Glico Group
Address
2-4, Komatsubara-cho, Kita-ku, Osaka, Japan
Tel
+81-6-6477-8201
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033268
