UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028830 |
|---|---|
| Receipt number | 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 14:58:39 |
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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
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
c.goto@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032998
