UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034010 |
|---|---|
| Receipt number | R000038347 |
| Scientific Title | A verification test of the intestinal regulation effect by consumption of the food containing lactic acid bacterium |
| Date of disclosure of the study information | 2020/03/31 |
| Last modified on | 2020/10/09 11:34:25 |
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Basic information
Public title
A verification test of the intestinal regulation effect by consumption of the food containing lactic acid bacterium
Acronym
A verification test of the intestinal regulation effect by consumption of the food containing lactic acid bacterium
Scientific Title
A verification test of the intestinal regulation effect by consumption of the food containing lactic acid bacterium
Scientific Title:Acronym
A verification test of the intestinal regulation effect by consumption of the food containing lactic acid bacterium
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the intestinal regulation effect by consumption of the food containing lactic acid bacteria for four weeks
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
*Defecation frequency
*Volume of stool
Key secondary outcomes
*Property of stool
*Color of stool
*Gut microbiota
*Spoilage products in stool
*Short-chain fatty acids in stool
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Consume two tablets of test food with water a day for 4 weeks - Washout 4 weeks - Consume two tablets of placebo food with water a day for 4 weeks
Interventions/Control_2
Consume two tablets of placebo food with water a day for 4 weeks - Washout 4 weeks - Consume two tablets of test food with water a day for 4 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
| 59 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy males and females aged 20 to 59 years old.
(2) Subjects who defecate less than and equal to 5 times in a week.
(3) 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) Subjects who didn't undergo abdominal surgical operation within 6 month before the test.
(2) Subjects who didn't take antibiotics within 1 month before the test.
(3) Subjects who have allergy to test food.
(4) Subjects who are heavy drinkers of alcohol.
(5) Subjects who plan big change of lifestyle during the test.
(6) Subjects with tendency of chronic diarrhea.
(7) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver functions, kidney functions, cardiovascular system and digestive systems.
(8) Subjects who suspected serious infectious disease.
(9) Females who are pregnant (including the possibility of pregnancy) or are lactating.
(10) Subjects who have participated the other clinical test within 1 month before the test.
(11) Subjects who have consumed medicines and/or foods which affect intestinal environment (yogurt, lactic acid bacteria beverage, oligo-sugar, dietary fiber) in the last 2 weeks before the day of preliminary examination.
(12) Subjects who have a plan to start consuming medicines and/or foods which affect intestinal environment (yogurt, lactic acid bacteria beverage, oligo-sugar, dietary fiber) during examination.
(13) Subjects who donated over 200mL blood and/or blood components within a month to the current study.
(14) Males who donated over 400mL blood within the last 3 months to the current study.
(15) Females who donated over 400mL blood within the last 4 months to the current study.
(16) Males who will be collected over 1200mL blood and/or blood components, when the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study.
(17) Females who will be collected over 800mL blood and/or blood components when, the sampling amounts within the last 12 months are adding to the planned sampling amounts of this study.
(18) Others they have been determined ineligible by principal investigator or sub-investigator.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Suguru |
| Middle name | |
| Last name | Fujiwara |
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
ICHIBIKI CO., LTD.
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
Institutional review board of Chiyoda Paramedical Care Clinic
Address
2F Chusin 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
| 2020 | Year | 03 | Month | 31 | 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
30
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
| 2018 | Year | 07 | Month | 20 | Day |
Date of IRB
| 2018 | Year | 07 | Month | 19 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 09 | Month | 03 | Day |
Last modified on
| 2020 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038347
| Research Plan | |
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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