UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000038767 |
|---|---|
| Receipt number | R000041391 |
| Scientific Title | Effect confirmation test of probiotics food : BFF004, BFF003 for healthy adults with constipation tend - Open method - |
| Date of disclosure of the study information | 2024/03/31 |
| Last modified on | 2019/12/03 11:20:08 |
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Basic information
Public title
Effect confirmation test of probiotics food : BFF004, BFF003 for healthy adults with constipation tend - Open method -
Acronym
Effect confirmation test of probiotics food : BFF004,BFF003 for healthy adults with constipation tend
Scientific Title
Effect confirmation test of probiotics food : BFF004, BFF003 for healthy adults with constipation tend - Open method -
Scientific Title:Acronym
Effect confirmation test of probiotics food : BFF004,BFF003 for healthy adults with constipation tend
Region
| Japan |
Condition
Condition
Healthy adult with a tendency for constipation
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of test food (probiotics) on the intestinal environment of subjects with a tendency for constipation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency
Key secondary outcomes
16S rRNA metagenome analysis by next generation sequencer of intestinal bacterial flora.
Intestinal metabolite (metabolome analysis).
Satisfaction (VAS).
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest probiotics food:BFF004 three times a day, 1 package after meals for 2 weeks.
Interventions/Control_2
Ingest probiotics food:BFF003 three times a day, 1 package after meals for 2 weeks.
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.
(2)Subjects with a tendency for constipation at three to five times of defecation per week at the point of screening examination.
(3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Key exclusion criteria
(1)Subjects who falls in more than half a week to Bristol scale 1.
(2)Subjects who taking medicine.
(3)Subjects who taking health foods which is said to improve constipation at the point of screening examination.
(4)Subjects who having been taken ntestinal preparation and/or antibacterial drug within 2 weeks at the point of screening examination.
(5)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.
(6)Subjects who consuming large amounts of alcohol on a daily basis.
(7)Subjects with a digestive organ disease or surgical history who has an influence on digestive absorption and defecation.
(8)Subjects who are judged to be unsuitable as a subject from an answer of a subjective background questionnaire.
(9)Subjects who are pregnant or breast-feeding, or have the will of pregnancy during the study period.
(10)Subjects who participate in other clinical studies or who are in willing to participate to these studies using foods, drugs and/or cosmetics.
(11)Subjects who are judged as unsuitable for the study by the investigator for the other reasons.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Satoru |
| Middle name | |
| Last name | Suzuki |
Organization
Shinagawa Season Terrace Health Care Clinic
Division name
Head of medical examination department
Zip code
108-0075
Address
Shinagawa Season Terrace 5F, 1-2-17 Minatominami, Minato-ku, Tokyo
TEL
03-3452-3381
satoru_suzuki@sempos.or.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
1-9-7 Shibaura, Minato-ku, Tokyo
TEL
03-3452-7733
Homepage URL
Yoshi@kso.co.jp
Sponsor or person
Institute
KSO Corporation
Institute
Department
Personal name
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
Shinagawa Season Terrace Health Care Clinic
Address
1-2-17 Minatominami, Minato-ku, Tokyo
Tel
03-3452-3381
tomohiro_kogo@sempos.or.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
| 2024 | Year | 03 | Month | 31 | 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
100
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
| 2018 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 15 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 04 | Day |
Date of closure to data entry
| 2019 | Year | 04 | Month | 12 | Day |
Date trial data considered complete
| 2019 | Year | 05 | Month | 17 | Day |
Date analysis concluded
| 2019 | Year | 06 | Month | 28 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 12 | Month | 03 | Day |
Last modified on
| 2019 | Year | 12 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041391
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