UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000026274 |
|---|---|
| Receipt number | R000030173 |
| Scientific Title | An evaluation test for intestinal environment change in consumption of the spore-forming lactic acid bacteria |
| Date of disclosure of the study information | 2017/02/24 |
| Last modified on | 2020/10/05 18:24:38 |
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Basic information
Public title
An evaluation test for intestinal environment change in consumption of the spore-forming lactic acid bacteria
Acronym
An evaluation test for intestinal environment change in consumption of the spore-forming lactic acid bacteria
Scientific Title
An evaluation test for intestinal environment change in consumption of the spore-forming lactic acid bacteria
Scientific Title:Acronym
An evaluation test for intestinal environment change in consumption of the spore-forming lactic acid bacteria
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the influence for intestinal environment by consumption of the spore-forming lactic acid bacteria.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
*Improvement of bowel movement
*Evaluation of intestinal microbiota by 16S metagenomic analysis
* Evaluation of intestinal metabolites by metabolome analysis
Key secondary outcomes
* Skin tests
* The incidence of adverse events
* The incidence of side effects
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Cluster
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
Take 1 tablet of test food at a time, 3 times a day after every meal, for 28 days -- Washout 4 weeks --Take 1 tablet of placebo at a time, 3 times a day after every meal, for 28 days
Interventions/Control_2
Take 1 tablet of placebo at a time, 3 times a day after every meal, for 28 days -- Washout 4 weeks -- Take 1 tablet of test food at a time, 3 times a day after every meal, for 28 days
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
| 30 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Healthy males and females aged 30 to 49 years old. (Target half a ratio of men and women)
2) Subjects who defecate 3 to 5 times in a week.
3) Subjects who do not routinely use medicines or the gastrointestinal related health foods during the examination period.
4) Subjects who show understanding of the study procedures and agreement with participating the study by written informed consent prior to the study.
Key exclusion criteria
1)Subject who concern difficult to carry out skin test, due to having birthmarks, scratches and a lot of acne on the skin.
2) Subject who have undergone abdominal surgery within 6 months.
3) Subject who took antibiotics within 6 months.
4) Subject who have allergy to the test food.
5) Smoker
6) Subjects whose consort or partner also participates to same clinical test.
7) Subjects who plan big change of lifestyle during test period.
8) Subjects with tendency of chronic diarrhea.
9) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart.
10) Subjects who suspected chronic or serious infectious disease.
11) Females who are pregnant or are lactating. And/or females who are the possibility of pregnancy.
12) Subjects who have participated in other clinical studies within 3 months.
13) Subjects who routinely use food for specific health use, functional foods and/or health foods.
14) Other subjects who have been determined ineligible by principal investigator or sub-investigator.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Katsuhisa |
| Middle name | |
| Last name | Sakano |
Organization
CPCC Company Limited
Division name
Clinical Research Planning Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
cpcc-contact@cpcc.co.jp
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Planning & Sales Department
Zip code
101-0047
Address
4F Chusin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, JAPAN
TEL
03-5297-3112
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
CPCC Company Limited
Institute
Department
Personal name
Funding Source
Organization
Metagen, Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
DAIICHI SANKYO HEALTHCARE CO., LTD.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Chushin Building, 3-3-5 Uchikanda Chiyoda-ku, Tokyo 101-0047, Japan
Tel
03-5297-5548
IRB@cpcc.co.jp
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
| 2017 | Year | 02 | Month | 24 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
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
| 2017 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 25 | 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 | 02 | Month | 23 | Day |
Last modified on
| 2020 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030173
