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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000038770
Receipt No. R000044201
Scientific Title Verification test of Bifidobacterium bifidum F1000 survival in human digestive tract - Open method -
Date of disclosure of the study information 2020/12/27
Last modified on 2021/01/25

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Basic information
Public title Verification test of Bifidobacterium bifidum F1000 survival in human digestive tract - Open method -
Acronym Verification test of Bifidobacterium bifidum F1000 survival in human digestive tract
Scientific Title Verification test of Bifidobacterium bifidum F1000 survival in human digestive tract - Open method -
Scientific Title:Acronym Verification test of Bifidobacterium bifidum F1000 survival in human digestive tract
Region
Japan

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

Objectives
Narrative objectives1 To confirm the viability in the human gastrointestinal tract of the strain to be blended in Biofermin Lactic acid bacteria Supplements by using feces.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Detection of viable bacteria of Bifidobacterium bifidum F1000 in feces
Key secondary outcomes Interview
Self-resevotable symptom

Base
Study type Interventional

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

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Take Biofermin Lactic acid bacteria Supplements three times a day, one after meals, for 6 days.
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)Males and females from 20 to 64 years of age who have daily defecation.
(2)Subjects who usually have three meals a day.
(3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria (1)Subjects who having been taken intestinal preparation and/or antibacterial drug within 2 weeks at the point of screening examination.
(2)Subjects who taking medicine.
(3)Subjects who taking health foods that are said to improve constipation at the point of screening examination.
(4)Subjects who are not able to stop consumption of foods containing lactic acid bacteria, bifidobacteria, natto bacteria, oligosaccharides, dietary fibers, high amount of sugar alcohol and/or other health foods including food for specified health use, which influence intestinal regulation during the study period.
(5)Subjects with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation.
(6)Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
(7)Subjects who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics.
(8)Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size 10

Research contact person
Name of lead principal investigator
1st name Masahiko
Middle name
Last name Tokushima
Organization Maebashi North Hospital
Division name Director
Zip code 371-0054
Address 692 Shimohosoi-machi, Maebashi-shi, Gumma
TEL 027-235-3333
Email sagawa@mc-connect.co.jp

Public contact
Name of contact person
1st name Yoshika
Middle name
Last name Komori
Organization KSO Corporation
Division name Sales Department
Zip code 105-0023
Address 7F Shibaura Omodaka Bld., 1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL 03-3452-7733
Homepage URL
Email yoshi@kso.co.jp

Sponsor
Institute KSO Corporation
Institute
Department

Funding Source
Organization Biofelmin 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 Ethical Committee of Kobuna Orthopedics Clinic
Address 5-656-17 Joto-machi, Maebashi-shi, Gumma
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

Other administrative information
Date of disclosure of the study information
2020 Year 12 Month 27 Day

Related information
URL releasing protocol Protocol is unpublished, due to including confidential information
Publication of results Unpublished

Result
URL related to results and publications Results is published in only UMIN
Number of participants that the trial has enrolled 10
Results Viable of Bifidobacterium bifidum F1000 was detected in feces
Results date posted
2021 Year 01 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics Healthy adults who have daily defecation (n=10)
Sex (m : f) 3 : 7
Age (y) 43.0+-10.9(mean+-SD)
Height (cm) 167.5+-9.4(mean+-SD)
Weight (kg) 67.0+-12.7(mean+-SD)
BMI 23.7+-2.3(mean+-SD)
Participant flow Enrolled participants 10
No dropout participants
Adverse events No adverse events
Outcome measures Detection of viable bacteria of Bifidobacterium bifidum F1000 in feces
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 10 Month 08 Day
Date of IRB
2019 Year 11 Month 14 Day
Anticipated trial start date
2019 Year 11 Month 25 Day
Last follow-up date
2019 Year 12 Month 27 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2020 Year 02 Month 26 Day

Other
Other related information

Management information
Registered date
2019 Year 12 Month 03 Day
Last modified on
2021 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044201

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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