UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011675 |
|---|---|
| Receipt number | R000013652 |
| Scientific Title | Improvement of bowel movement and fecal properties by the intake of Bacillus coagulans lilac-01-contained Okara powder |
| Date of disclosure of the study information | 2013/09/07 |
| Last modified on | 2015/09/24 15:51:18 |
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Basic information
Public title
Improvement of bowel movement and fecal properties by the intake of Bacillus coagulans lilac-01-contained Okara powder
Acronym
Effect of Bacillus coagulans lilac-01 on bowel movement and fecal properties
Scientific Title
Improvement of bowel movement and fecal properties by the intake of Bacillus coagulans lilac-01-contained Okara powder
Scientific Title:Acronym
Effect of Bacillus coagulans lilac-01 on bowel movement and fecal properties
Region
| Japan |
Condition
Condition
constipation
Classification by specialty
| Gastroenterology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose is to evaluate the effects of Bacillus coagulans lilac-01 for bowel movement and fecal propertiesby double-blind, placebo-controlled test.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
questionnaire for defecatory conditions
Key secondary outcomes
VAS, fecal microbiota, fecal water content, fecal pH, fecal oeganic acid content, fecal ammonium, fecal substrate decomposition, fecal bile acid
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
Intake 2 g of Okara powder contained Bacillus coagulans lilac-01 dairy for two weeks.
Interventions/Control_2
Intake 2 g of Okara powder (placebo food) dairy for two 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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects suffered from constipation
Subjects we obtained written informed
consent for participation in the study.
Key exclusion criteria
(1) Subjects with a history of
gastrointestinal cancer
(2) Subjects with serious disease
and infection
(3) Subjects with previous
gastrointestinal surgery
(4) Subjects with IBS
(5) Subjects with a history of allergy to
medicine and food, especially soy
bean.
(6) heavy smokers and alcohol addict and
subjects that spend irregular
lifestyle.
(7) Subjects who donate 200ml or more of
blood within 4 wks, or who donate
400ml or more of blood within 12 wks
before screening or subjects who
donate plasma or platelet within 4 wks
before supplementation started.
(8) There is possibility of the inside of
the present pregnancy or pregnancy, or
it is under breast-feeding.
(9) Subjects who participated in other
clinical trials within the past one
months before the start of this
clinical trial.
(10) Subjects whom the attending
physician judges to be an
inappropriate subject.
Target sample size
700
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Nishihira, Jun |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
Address
59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Director of center. Nishihira, Jun |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
Address
59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido
TEL
011-385-4430
Homepage URL
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
Hokkaido National Federation of Small Business Associations
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Aterio bio Co., Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
YES
Study ID_1
01120159
Org. issuing International ID_1
Hokkaido National Federation of Small Business Associations
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道情報大学 保健センター（北海道）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.ncbi.nlm.nih.gov/pubmed/25338680
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
| 2013 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 10 | Month | 21 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 06 | Day |
Last modified on
| 2015 | Year | 09 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013652
