UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038770 |
|---|---|
| Receipt number | 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 10:51:39 |
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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
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
yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044201
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