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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000028830
Receipt No. R000032998
Scientific Title Effect of intake of spore forming lactic acid bacteria containing food on improvement of defecation and intestinal environment for subjects with constipation tendency : A randomized, double blinded, placebo controlled study
Date of disclosure of the study information 2018/10/25
Last modified on 2018/10/25

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Basic information
Public title Effect of intake of spore forming lactic acid bacteria containing food on improvement of defecation and intestinal environment for subjects with constipation tendency : A randomized, double blinded, placebo controlled study
Acronym Effect of intake of spore forming lactic acid bacteria containing food on improvement of defecation and intestinal environment for subjects with constipation tendency
Scientific Title Effect of intake of spore forming lactic acid bacteria containing food on improvement of defecation and intestinal environment for subjects with constipation tendency : A randomized, double blinded, placebo controlled study
Scientific Title:Acronym Effect of intake of spore forming lactic acid bacteria containing food on improvement of defecation and intestinal environment for subjects with constipation tendency
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of intake of spore forming lactic acid bacteria containing food on defecation and intestinal environment for subjects with constipation tendency
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Defecation frequency,Defecation days.
Evaluate at points of 2-week of consumption.
Key secondary outcomes Intestinal flora (T-RFLP, Real-Time PCR), Stool output, Fecal condition, Questionnaire

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 Ingestion of the test product for 2 consecutive weeks
Interventions/Control_2 Ingestion of placebo for 2 consecutive 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
64 years-old >=
Gender Male and Female
Key inclusion criteria (1)Males and Females from 20 to 64 years of age
(2)Subjects with a tendency for constipation (three to five times of defecation per week)
Key exclusion criteria (1)Subjects routinely taking medicine or health food which may influence bowel movement and take foods of lactic acid bacteria.
(2) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative
(3) Subjects currently undergoing treatment with digestive diseases that affect the study or having a surgical history of digestive system (except appendicectomy)
(4) Subjects having diseases (irritable enteritis, ulcerative colitis, etc.) affecting bowel movement or a history of these diseases
(5) Subjects who are under medication or having a history of serious diseases for which medication was required
(6) Subjects who are under treatment or have a history of serious disease(e.g., diabetes, liver disease, kidney disease, or heart disease)
(7) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality
(8) Subjects having possibilities for emerging allergy related to the study
(9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(10) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study
(11) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating
(12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(13) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuko Watanabe
Organization MITSUBISHI-CHEMICAL FOODS CORPORATION
Division name Technology Department Division 2
Zip code
Address 1-1-1,Marunouchi,Chiyoda-ku,Tokyo, Japan
TEL 03-6748-7426
Email watanabe.yuuko.mw@m-chemical.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Chiharu Goto
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
Address 1-20-2, Ebisunishi, Shibuya-ku, Tokyo, Japan
TEL 03-5459-5329
Homepage URL
Email c.goto@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

Funding Source
Organization MITSUBISHI-CHEMICAL FOODS CORPORATION
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 10 Month 25 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
The changes in stool frequency between the two periods in the per protocol population (n=58) were mean3.0 SD3.0 and mean1.6 SD2.9 times/2 weeks in B.coagulans-containing food group and placebo group, respectively (P=0.09). 
The intergroup difference was significant in the population (n=53) after excluding subjects who took an antibiotic or experienced a change in eating habit (mean3.0 SD3.0 and mean1.2 SD2.8 times/2 weeks in B.coagulans-containing food group  and placebo group, respectively, P=0.03). No significant intergroup differences were found in the changes in stool properties, defecation amount, and intestinal flora pattern. 


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
2017 Year 08 Month 10 Day
Date of IRB
Anticipated trial start date
2017 Year 08 Month 26 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
2017 Year 08 Month 25 Day
Last modified on
2018 Year 10 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032998

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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