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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016777
Receipt No. R000019466
Scientific Title The beneficial effect of a newly developed functional food (beverage) containing Lactobacillus powder on human gastrointestinal function.
Date of disclosure of the study information 2015/03/12
Last modified on 2017/01/25

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Basic information
Public title The beneficial effect of a newly developed functional food (beverage) containing Lactobacillus powder on human gastrointestinal function.
Acronym The beneficial effect of a beverage containing Lactobacillus powder on human gastrointestinal function.
Scientific Title The beneficial effect of a newly developed functional food (beverage) containing Lactobacillus powder on human gastrointestinal function.
Scientific Title:Acronym The beneficial effect of a beverage containing Lactobacillus powder on human gastrointestinal function.
Region
Japan

Condition
Condition Individuals with a tendency for constipation or loose stool
Classification by specialty
Not applicable
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In order to investigate the efficacy and safety of the intake of the test beverages for 3 weeks on persons with constipation or frequent loose stool.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Defecation frequency, defecation days, fecal condition
Key secondary outcomes Intestinal microflora composition, organic acids, putrefactive products, questionnaire for QOL

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 beverage (containing Lactobacillus powder)
Duration: 3 weeks
Amount: 200 mL/ bottle, 1 bottle daily
Interventions/Control_2 Control
Placebo beverage
Duration: 3 weeks
Amount: 200 mL/ bottle, 1 bottle daily
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 males and females from 20 to 70 years of age.
(2) Those with a tendency for constipation (at 4 times or less of defecation per week), and for loose stool (at 10 times or more of defecation per week).
(3) Those taking regular meals.
Key exclusion criteria (1) A medical history of severe disorders, or continuous medical treatment.
(2) A surgical history of digestive system (except appendicectomy)
(3) Watery stool daily
(4) Those who are pregnant or have possibility to become pregnant during the study or breast-feeding.
(5) Constantly usage of supplements and/or functional foods (including Food for Specified Health Uses [FOSHU]) affecting the test results.
(6) Those having an extremely irregular diet habit, alternative work schedule, or work on midnight shift.
(7) Those who drink alcohol a lot.
(8) Withdrawal of whole blood more than 400mL within 12 weeks, or more than 200mL within 4 weeks, or withdrawal of blood components prior to the current study.
(9) Those judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size 120

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 Clinical Support Corporation
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 Calpis Co. Ltd.
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
2015 Year 03 Month 12 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.microbecolhealthdis.net/index.php/mehd/article/view/30259
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
2015 Year 02 Month 12 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 12 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
2015 Year 03 Month 11 Day
Last modified on
2017 Year 01 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019466

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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