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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000025349
Receipt No. R000029179
Scientific Title Evaluation of the safety of a functional food containing lactic acid bacteria in healthy adults
Date of disclosure of the study information 2018/03/14
Last modified on 2017/07/11

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Basic information
Public title Evaluation of the safety of a functional food containing lactic acid bacteria in healthy adults
Acronym Evaluation of the safety of a functional food containing lactic acid bacteria
Scientific Title Evaluation of the safety of a functional food containing lactic acid bacteria in healthy adults
Scientific Title:Acronym Evaluation of the safety 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 a 12-week consumption of food containing lactic acid bacteria
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 Intervention
Test beverages (containing lactic acid bacteria)
Duration: 12 weeks
Interventions/Control_2 Control
Negative control beverages
Duration: 12 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
Email 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
Email takehara@csc-smo.co.jp

Sponsor
Institute Asahi Group Holdings, Ltd.
Institute
Department

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
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

Other administrative information
Date of disclosure of the study information
2018 Year 03 Month 14 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
2016 Year 12 Month 21 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
2016 Year 12 Month 21 Day
Last modified on
2017 Year 07 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029179

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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