UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039276 |
|---|---|
| Receipt number | R000044790 |
| Scientific Title | Experimental study of the intestinal environment improving effect by intake of lactic acid bacteria producing extract |
| Date of disclosure of the study information | 2020/01/28 |
| Last modified on | 2020/06/01 16:20:37 |
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Basic information
Public title
Experimental study of the intestinal environment improving effect by intake of lactic acid bacteria producing extract
Acronym
Experimental study of the intestinal environment improving effect by intake of lactic acid bacteria producing extract
Scientific Title
Experimental study of the intestinal environment improving effect by intake of lactic acid bacteria producing extract
Scientific Title:Acronym
Experimental study of the intestinal environment improving effect by intake of lactic acid bacteria producing extract
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluate the intestinal environment improving effect by intake of lactic acid bacteria producing extract for 4 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Creatinine-corrected urinary indoxyl sulfate levels 4 weeks after continuous intake
Key secondary outcomes
Questionnaire(Defection status,
physical condition, etc) 4 weeks after continuous intake
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
Intake 10ml of lactic acid bacteria producing extract daily for 4 weeks.
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
| 30 | years-old | <= |
Age-upper limit
| 50 | years-old | > |
Gender
Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the exam, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate with a written document
2.Healthy Japanese women who are 30 years old or more and under 50 years old
3.Persons who have constipation tendencies from the preliminary survey questionnaire
4.The top 30 urinary indoxyl sulfate levels at screening
Key exclusion criteria
1.Persons who have chronic illness
2.Persons who are pregnant, planning or hoping to be pregnant during the study period, breastfeeding
3.Persons who are taking medications that affect the intestinal environment, such as intestinal medicines, laxatives, and antibiotics
4.Persons who are taking dietary fiber or lactic acid bacteria supplements that improve the intestinal environment
5.Persons who are allergic to soy
6.Persons who have participated in other tests within the first month before the start of the test, or those who intend to participate in another exam after consenting to this exam
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yasuhiro |
| Middle name | |
| Last name | Sasuga |
Organization
B&S corporation Co., Ltd.
Division name
Production & Development Division
Zip code
102-0073
Address
4-1-28 Kudankita, Chiyoda-ku, Tokyo, JAPAN
TEL
03-3288-0115
y-sasuga@bandscorp.jp
Public contact
Name of contact person
| 1st name | Miho |
| Middle name | |
| Last name | Matsumoto |
Organization
Healthcare Systems Co., Ltd.
Division name
Sales Planning Department
Zip code
105-0004
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
TEL
050-3640-3595
Homepage URL
matsumoto@hc-sys.jp
Sponsor or person
Institute
B&S corporation Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
B&S corporation Co., Ltd.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Tokyo Medical and Dental University
Healthcare Systems Co., Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Healthcare Systems Co., Ltd.
Address
Nisshin Tatemono Shinbashi Bld. 7F, 4-6-15 Shinbashi, Minato-ku, Tokyo, JAPAN
Tel
03-6809-2722
kakehashi@hc-sys.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 | 01 | Month | 28 | 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
30
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 | 01 | Month | 24 | Day |
Date of IRB
| 2020 | Year | 01 | Month | 24 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 06 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | 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 | 01 | Month | 28 | Day |
Last modified on
| 2020 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000044790
