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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032285
Receipt No. R000036817
Scientific Title Safety excessive intake study of drink-B containing lactic acid bacteria
Date of disclosure of the study information 2018/04/23
Last modified on 2018/08/24

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Basic information
Public title Safety excessive intake study of drink-B containing lactic acid bacteria
Acronym Safety excessive intake study of drink-B containing lactic acid bacteria
Scientific Title Safety excessive intake study of drink-B containing lactic acid bacteria
Scientific Title:Acronym Safety excessive intake study of drink-B 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,food allergy,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
Email 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
Email n2-oka@apoplus.co.jp

Sponsor
Institute APO PLUS STATION CO., LTD.
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036817

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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