UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025711 |
|---|---|
| Receipt number | R000029586 |
| Scientific Title | Safety evaluation of excessive intake of a functional food containing lactic acid bacteria in healthy adults. |
| Date of disclosure of the study information | 2018/02/26 |
| Last modified on | 2017/07/11 09:38:01 |
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Basic information
Public title
Safety evaluation of excessive intake of a functional food containing lactic acid bacteria in healthy adults.
Acronym
Safety evaluation of excessive intake of a functional food containing lactic acid bacteria.
Scientific Title
Safety evaluation of excessive intake of a functional food containing lactic acid bacteria in healthy adults.
Scientific Title:Acronym
Safety evaluation of excessive intake of a functional food containing lactic acid bacteria.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In order to investigate the safety of excessive consumption of food containing lactic acid bacteria for 4 weeks
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The incidence of side effects during intervention
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Test beverages (containing lactic acid bacteria)
Duration: 4 weeks
Interventions/Control_2
Negative control beverages
Duration: 4 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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1) Japanese untreated males and females from 20 to 69 years of age.
(2) Individuals who are judged as suitable for the study based on the results of preliminary clinical and physical examination.
(3) Individuals who can have an examination in a designated day
(4) Individuals who gave the written informed consent before the study.
Key exclusion criteria
(1) Individuals who have hepatic disorders, renal and/or heart failure, organ damages, and/or other severe disorders.
(2) A surgical history of digestive system (except appendicectomy)
(3) Individuals who undergo medical treatment for chronic diseases.
(4) Individuals who are pregnant or have possibility to become pregnant during the study or breast-feeding.
(5) Individuals who drink alcohol a lot.
(6) Individuals who have tendency to get diarrhea by consuming milk or lactic acid bacteria.
(7) With allergy to milk and/or soybean.
(8) Individuals judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuhiko Takano |
Organization
Medical Corporation Hokubukai
Division name
Utsukushigaoka Hospital
Zip code
Address
61-1 Sin-ei, Kiyota-ku, Sapporo, Hokkaido 004-0839, Japan
TEL
001-882-0111
info@csc-smo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Isao Takehara |
Organization
Clinical Support Corporation
Division name
PI-Food Service Division
Zip code
Address
4-1 South 1 West 8, Chuo-ku, Sapporo, Hokkaido 060-0061, Japan
TEL
011-223-3130
Homepage URL
takehara@csc-smo.co.jp
Sponsor or person
Institute
Asahi Group Holdings, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Holdings, 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
Address
Tel
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
| 2018 | Year | 02 | Month | 26 | 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
| 2016 | Year | 11 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 01 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 01 | Month | 17 | Day |
Last modified on
| 2017 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029586
