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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000042392
Receipt No. 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 2021/02/26

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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
Email 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
Email IRB_dis@dena.com

Sponsor
Institute DeNA Life Science, Inc
Institute
Department

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
Email 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 No longer recruiting
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
2021 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048383

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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