UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042392 |
|---|---|
| Receipt number | R000048383 |
| Scientific Title | Effects of Bifidobacterium on immune and gastrointestinal function - A Randomized, Double-blind, Placebo-controlled, Parallel-group Study - |
| Date of disclosure of the study information | 2021/06/30 |
| Last modified on | 2022/04/07 16:05:23 |
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Basic information
Public title
Effects of Bifidobacterium on immune and gastrointestinal function
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Study -
Acronym
Effects of Bifidobacterium on immune and gastrointestinal function
Scientific Title
Effects of Bifidobacterium on immune and gastrointestinal function
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Study -
Scientific Title:Acronym
Effects of Bifidobacterium on immune and gastrointestinal function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To evaluate the effects of Bifidobacterium intake on immune and gastrointestinal function in Japanese male and female over 50 years old
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
NK cell activity
Key secondary outcomes
Salivary secretion rate
IgA concentration and secretion rate in saliva
IgA concentration in feces
Peripheral blood pDC activity
Blood cytokine level(IFN-alpha2a, IFN-gamma, IL-6, IL-12, IL-18)
Gut microbiota
Profile of mood states
Subjective sensation questionnaire
Clinical symptoms (Online survey)
Incidence rate of upper respiratory tract infection
SNPs
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
Participants will intake one active capsule per day for twelve weeks. They will also get clinical tests before and 4, 8, 12 weeks after the beginning of the intervention.
Interventions/Control_2
Participants will intake one placebo capsule per day for twelve weeks. They will also get clinical tests before and 4, 8, 12 weeks after the beginning of the intervention.
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Healthy men and women over 50 years old
2. Subjects who have given written consent to participate in researches conducted by DeNA Life Science using samples and information obtained through MYCODE, the genetic testing service
3. Subjects who have be given sufficient explanation about the purpose and contents of this study, volunteer for voluntary participation with good understanding, and can consent to this examination in writing
4. Subjects who were considered appropriate to participate in this study by the study doctor
Key exclusion criteria
1. Subjects who are receiving continuous pharmaceutical treatment
2. Subjects with previous and/or current medical history of serious disease (e.g. liver, kidney, heart, lung, blood)
3. Subjects with prevalence of digestive system comorbidities and previous medical history of the system
4. Subjects with serious anemia
5. Subjects with a risk of presenting allergic reaction to test capsule, other food, and medicine
6. Subjects who are taking medicine, supplement, and/or any food/functional food claiming an effect on immune function related evaluation items
7. Females who are pregnant and/or lactating, or those with willingness/intention to become pregnant during the study
8. Subjects that plan to have irregular life cycle (e.g. midnight shift work, long-term travel) and/or those with extremely irregular dining and sleep habits
9. Subjects with current or past (less than 3 months) experience of participating in other clinical studies (excluding non-invasive observational studies)
10. Subjects who are judged by the principal investigator to be unsuitable as the study
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Jun |
| Middle name | |
| Last name | Ohi |
Organization
DeNA Life Science, Inc
Division name
Member of the Board
Zip code
150-8510
Address
Shibuya Hikarie. 2-21-1. Shibuya. Shibuya-ku, Tokyo
TEL
03-4366-7219
IRB_dis@dena.com
Public contact
Name of contact person
| 1st name | Tatsuya |
| Middle name | |
| Last name | Matsuda |
Organization
DeNA Life Science, Inc
Division name
MYCODE service Dept
Zip code
150-8510
Address
Shibuya Hikarie. 2-21-1. Shibuya. Shibuya-ku, Tokyo
TEL
03-4366-7219
Homepage URL
IRB_dis@dena.com
Sponsor or person
Institute
DeNA Life Science, Inc
Institute
Department
Personal name
Funding Source
Organization
Biofermin Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of DeNA Life Science, Inc
Address
Shibuya Hikarie. 2-21-1. Shibuya. Shibuya-ku, Tokyo
Tel
03-4366-7219
IRB_dis@dena.com
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
| 2021 | Year | 06 | 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
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
| 2020 | Year | 09 | Month | 28 | Day |
Date of IRB
| 2021 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2021 | Year | 01 | Month | 14 | Day |
Last follow-up date
| 2021 | Year | 04 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 11 | Month | 09 | Day |
Last modified on
| 2022 | Year | 04 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048383
