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Recruitment status Completed
Unique ID issued by UMIN UMIN000011675
Receipt No. 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

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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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Email 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
Email nishihira@do-johodai.ac.jp

Sponsor
Institute Hokkaido Information University
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013652


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