UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037753 |
|---|---|
| Receipt number | R000043027 |
| Scientific Title | Effect of synbiotics on intestinal environment in healthy subjects |
| Date of disclosure of the study information | 2020/10/01 |
| Last modified on | 2020/12/24 16:28:00 |
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Basic information
Public title
Effect of synbiotics on intestinal environment in healthy subjects
Acronym
Effect of synbiotics on intestinal environment
Scientific Title
Effect of synbiotics on intestinal environment in healthy subjects
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 with dietary fiber on intestinal environment
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
16S rRNA gene based metagenome analysis of gut microbiome
Key secondary outcomes
fecal bifidobacteria
fecal short-chain fatty acids
Base
Study type
Interventional
Study design
Basic design
Parallel
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
100g beverage containing bifidobacterium GCL2505 (1.10^10 CFU/mL) and inulin (2g) (once a day for 4 weeks), observation period (3 weeks, post-treatment period (4 weeks)
Interventions/Control_2
100g placebo beverage containing neither bifidobacterium GCL2505 nor inulin (once a day for 4 weeks), observation period (3 weeks, post-treatment period (4 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 5 times per week
Key exclusion criteria
1. Subjects who regularly use intestinal and constipation drugs (including strong laxatives)
2. Subjects who are heavy drinkers or alcoholics.
3. Subjects who consume following foods (daily or during ingestion period): food containing lactic acid bacteria and bifidobacteria (fermented milk, beverages, supplement etc.,), prebiotics and oligosaccharides, food containing a large amount of dietary fiber (beverages, supplements etc.,)
4. Subjects who have a disease that requires emergency treatment, or have serious complications
5. Subjects who have a medical history of digestive diseases or surgeries affecting digestion and absorption
6. Subjects with food allergy
7. Subjects who are pregnant or plan to become pregnant , or breast-feeding during the study
8. Subjects who are participating in other clinical trials that intake/apply any foods or drugs.
Target sample size
40
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 Sciences
Zip code
555-8502
Address
4-6-5, Utajima, Nishiyogogawa-ku, Osaka, Japan.
TEL
050-1745-4313
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, Nishiyogogawa-ku, Osaka, Japan
TEL
050-1745-4313
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
| 2020 | Year | 10 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043027
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr_view.cgi?recptno=R000043027
Number of participants that the trial has enrolled
40
Results
UniFrac distance analysis results showed a significant change in the gut microbiome composition of synbiotics group in comparison with that of placebo group. During the intervention period in synbiotics group, there was an increase in the abundance ratio of genus Bifidobacterium and Anaerostipes and a decrease in genus Clostridium.
The quantitative PCR results showed that the total number of fecal Bifidobacterium significantly increased in only synbiotics group during the intervention period.
Results date posted
| 2020 | Year | 12 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Unpublished
Participant flow
Number of Intention To Treat: 40
Number of Full Analysis Set: 33
Number of Per Protocol Set: 31
Adverse events
Nothing
Outcome measures
Primary outcomes
16S rRNA gene-based metagenome analysis of gut microbiome
Secondary outcomes
The total number of fecal Bifidobacteria
The short-chain fatty acids concentrations
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 07 | Month | 25 | Day |
Date of IRB
| 2019 | Year | 07 | Month | 31 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 06 | Day |
Date of closure to data entry
| 2020 | Year | 02 | Month | 10 | Day |
Date trial data considered complete
| 2020 | Year | 02 | Month | 27 | Day |
Date analysis concluded
| 2020 | Year | 09 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 08 | Month | 21 | Day |
Last modified on
| 2020 | Year | 12 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043027
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| Registered date | File name |
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