UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016777 |
|---|---|
| Receipt number | 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 17:29:52 |
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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
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
Clinical Support Corporation
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
Calpis Co. Ltd.
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019466
