UMIN-CTR Clinical Trial

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	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048383