UMIN-CTR Clinical Trial

Basic information
Public title	Study on the arrival of live bifidobacteria in the gastrointestinal tract. -Single group before-after test-
Acronym	Study on the arrival of live bifidobacteria in the gastrointestinal tract.
Scientific Title	A study on the viability of bifidobacteria ingested as an acid-resistant processed preparation in the digestive tract. -Single group before-after test-
Scientific Title:Acronym	A study on the viability of bifidobacteria ingested as an acid-resistant processed preparation in the digestive tract.
Region	Japan

Condition
Condition	Healthy volunteer
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Verification of survival of bifidobacteria in human feces before and after ingestion of acid-resistant bifidobacteria supplement
Basic objectives2	Others
Basic objectives -Others	Verification of supplement on acid resistance processing technology
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection of certain live Bifidobacterium in feces. Time: Before and after the intervention (0day, 14days)
Key secondary outcomes	Viable cell count of certain Bifidobacterium in feces

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Bifidobacterium-containing acid-resistant preparation Intervention period:14days
Interventions/Control_2
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	1.Healthy men and women 20 to 64 years old 2.Subjects who have defecation every day and can collect stool at the designated date and time 3.Subjects who have received sufficient explanation about the purpose and content of the exam, have the ability to consent, voluntarily volunteered to participate after understanding it well, and agreed to participate in the exam in writing.
Key exclusion criteria	1. Subjects who tend to have loose stools or constipation 2. Subjects who cannot stop the intake of foods containing certain Bifidobacterium from the screening test to the end of the 2-week test. 3. Subjects who are taking drugs that affect digestion and absorption, such as antibiotics 4. Subjects who cannot stop the intake of medicines, quasi-drugs, and health foods that affect the test during the test period. 5. Subjects with food allergies 6. Subjects who consume a large amount of alcohol on a daily basis 7. Subjects who have urgent medical treatment or have serious complications 8. Subjects with digestive disorders or surgical history that affect digestion and absorption and defecation 9. Subjects with a history of irritable bowel syndrome or a current medical history 10. Subjects background Persons who are judged to be inappropriate as subjects based on the answers to the questionnaire 11. Pregnant, willing to become pregnant during the exam, breastfeeding 12. Subjects with a history of drug dependence, alcohol dependence, or current medical history 13. Subjects who have participated in or are willing to participate in tests that take other foods or use drugs, and tests that apply cosmetics and drugs 14. Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Kei Middle name Last name Yui
Organization	FANCL Corporation
Division name	Research Institute, Health science research center
Zip code	244-0806
Address	12-13, Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL	045-820-3443
Email	ke-yui@fancl.co.jp

Public contact
Name of contact person	1st name Eiji Middle name Last name Yoshikawa
Organization	KSO Corporation
Division name	Sales department
Zip code	105-0023
Address	1-9-7, Shibaura, Minato-ku, Tokyo The 7th floor of Shibaura omodaka building
TEL	03-3452-7733
Homepage URL
Email	yoshikawa@kso.co.jp

Sponsor
Institute	KSO Corporation
Institute
Department

Funding Source
Organization	FANCL Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Ethical Committee of Kobuna Orthopedics Clinic
Address	5-656-17Joutou-machi,Maebashi-shi,Gunma
Tel	027-212-5608
Email	sagawa@mc-connect.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	品川シーズンテラス健診クリニック/Shinagawa Season Terrace Health Care Clinic

Other administrative information
Date of disclosure of the study information	2021 Year 09 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
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	2021 Year 03 Month 02 Day
Date of IRB	2021 Year 03 Month 04 Day
Anticipated trial start date	2021 Year 03 Month 21 Day
Last follow-up date	2021 Year 04 Month 25 Day
Date of closure to data entry	2021 Year 05 Month 10 Day
Date trial data considered complete	2021 Year 05 Month 20 Day
Date analysis concluded	2021 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date	2021 Year 03 Month 19 Day
Last modified on	2021 Year 09 Month 17 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049871