UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032284 |
|---|---|
| Receipt number | R000036815 |
| Scientific Title | Safety excessive intake study of drink-A containing lactic acid bacteria |
| Date of disclosure of the study information | 2018/04/23 |
| Last modified on | 2018/08/24 13:01:31 |
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Basic information
Public title
Safety excessive intake study of drink-A containing lactic acid bacteria
Acronym
Safety excessive intake study of drink-A containing lactic acid bacteria
Scientific Title
Safety excessive intake study of drink-A containing lactic acid bacteria
Scientific Title:Acronym
Safety excessive intake study of drink-A containing lactic acid bacteria
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Confirm the safety of the beverage containing Lactobacillus casei NY 1301 strain on healthy adults,3-fold quantity of recommended daily intake for 4 weeks.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Frequency of side effects
Key secondary outcomes
Frequency of adverse events, Physical examination, Blood test, Urinalysis, Background factors, Lifestyle background
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
Intake of drink containing lactic acid bacteria for 4 weeks. (3-fold quantity of recommended daily intake)
Interventions/Control_2
Intake of placebo drink for 4 weeks.(3-fold quantity of recommended daily intake)
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)Subjects from 20 to 69 years-old
2)Subjects undergoing none of medical treatments
3)Subjects who can record daily logs daily during the designated period
4)Subjects who can record daily logs during the designated period
5)Subjects who can record diet records on specified days
Key exclusion criteria
1)Subjects with serious liver disease,renal /heart disease,organ disorder,diabetes,foodallergy,gastrointestinal disease,other serious diseases
2)Subjects allergic to a specific drug or food
3)Subjects allergic to samples in this study
4)Pregnants,lactating women or who is going to be pregnant during study
5)Subjects drawn blood over 200mL last 1 month,or over 400mL last3 months before consent acquisition date
6)Subjects who can't maintain everyday life habits
7)Subjects with a several variation of the amount of diet or movement
8)Subjects drink alcohol over 500mL in terms of beer per day
9)Subjects smoke over average 20 cigarettes per day
10)Subjects who can not refrain from using health foods,during the study
11)Subjects who can not take the test food as instructed
12)Subjects who have participated in the other clinical studies
13)Subjects judged as unsuitable for the study by the principal investigator for other reasons
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Moriyama |
Organization
Kanazawabunko Hospital
Division name
Vice president
Zip code
Address
2-6-22,Kamariyahigashi,Kanazawa-ku, Yokohama-shi,Kanagawa
TEL
045-785-3311
watanabe@kanabun-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Natsumi Oka |
Organization
APO PLUS STATION CO., LTD.
Division name
CRO Department Food Test Division
Zip code
Address
2-14-1,Nihonbashi,Chuo-ku,Tokyo
TEL
03-6386-8809
Homepage URL
n2-oka@apoplus.co.jp
Sponsor or person
Institute
APO PLUS STATION CO., LTD.
Institute
Department
Personal name
Funding Source
Organization
Nissin York 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
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
金沢文庫病院（神奈川県）、ゆきクリニック（東京都）、戸田中央総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 04 | Month | 23 | 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
| 2018 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2018 | Year | 04 | Month | 23 | 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
| 2018 | Year | 04 | Month | 17 | Day |
Last modified on
| 2018 | Year | 08 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036815
