UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052725 |
|---|---|
| Receipt number | R000060145 |
| Scientific Title | Study on Improvement of Intestinal Environment and Defecation by Intake of lactic acid bacillus A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study |
| Date of disclosure of the study information | 2023/11/07 |
| Last modified on | 2023/11/07 21:46:49 |
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Basic information
Public title
Study on Improvement of Intestinal Environment and Defecation by Intake of lactic acid bacillus
A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Acronym
Study on Improvement of Intestinal Environment and Defecation by Intake of lactic acid bacillus
A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Scientific Title
Study on Improvement of Intestinal Environment and Defecation by Intake of lactic acid bacillus
A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Scientific Title:Acronym
Study on Improvement of Intestinal Environment and Defecation by Intake of lactic acid bacillus
A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study
Region
| Japan |
Condition
Condition
Healthy 20s female
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to compare the effects of the intake of live or dead lactic acid bacteria on the defecation status of healthy young women in relation to changes in intestinal bacteria.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal microflora analysis (conducted twice, before and after ingestion of test product)
Stool record (recorded daily during the study period, including one week before and after the intake period)
Key secondary outcomes
Lifestyle survey (recorded every week during the study period, including one week before and after the intake period)
Weight and body composition (conducted twice before and after the intake period)
Base
Study type
Interventional
Study design
Basic design
Parallel
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
3
Purpose of intervention
Prevention
Type of intervention
| Other |
Interventions/Control_1
Group A: Dextrin (placebo group)
Intake period is 6 weeks.
One week before and after intake and 4 weeks after intake
One packet (1 g) per day
Interventions/Control_2
Group B: Dextrin + live lactobacilli (10 billion/g) (test product group-1)
Intake period is 6 weeks.
One week before and after intake and 4 weeks after intake
One packet (1 g) per day
Interventions/Control_3
Group C: Dextrin + dead lactobacilli (100 billion/g) (test product group-2)
Intake period is 6 weeks.
One week before and after intake and 4 weeks after intake
One packet (1 g) per day
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
| 29 | years-old | >= |
Gender
Female
Key inclusion criteria
(1) A healthy female in her 20s
(2) Persons who understand the research description and give their consent by their own signature.
Key exclusion criteria
(1) Persons who cannot restrict the use of medicines (laxatives, bowel regulators, etc.), health foods, foods for specified health uses, foods with functional claims, health supplements, supplements, etc. that may affect bowel movements, and foods that contain a large amount of lactic acid bacteria after the time consent is obtained
(2) Those who are currently receiving medication or outpatient treatment for various illnesses that prevent them from leading a daily life.
(3) Persons who are currently under the supervision of a physician for exercise or diet therapy.
(4) Persons who are at risk of developing food allergies due to the test foods.
(5) Persons with a current or previous history of drug or alcohol dependence.
(6) Persons with extremely irregular rhythm of life (eating, sleeping, extremely picky eaters, etc.)
(7) Those who are in the hospital for mental disorders (depression, etc.) or sleep disorders (insomnia, sleep apnea syndrome, etc.), or have a history of mental illness in the past.
(8) Those who have participated in other clinical trials (research) within 3 months prior to the date of consent, or have plans to participate in other clinical trials (research) during the study period.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Toshiro |
| Middle name | |
| Last name | Maruyama |
Organization
Ebara Foods Industry,Inc.
Division name
Creative Division Research Institute
Zip code
258-0015
Address
1408 Yamada,Oimachi,Ashigarakamigun,Kanagawa 258-0015,Japan
TEL
0465-85-5181
m.toshiro@ebarafoods.co.jp
Public contact
Name of contact person
| 1st name | Atsushi |
| Middle name | |
| Last name | Ohashi |
Organization
Ebara Foods industry,Inc.
Division name
Creative Division Research Institute
Zip code
258-0015
Address
1408 Yamada,Oimachi,Ashigarakamigun,Kanagawa 258-0015,Japan
TEL
0465-85-5181
Homepage URL
a.oohashi@ebarafoods.co.jp
Sponsor or person
Institute
Ebara Foods industry,Inc.
Creative Division Research Institute
Institute
Department
Personal name
Funding Source
Organization
Ebara Foods industry,Inc.
Creative Division Research Institute
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
Komazawa Women's University Institutional Review Board
Address
238 Sakahama, Inagi-shi Tokyo
Tel
0423507111
suishin-c@komajo.ac.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
東京都
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 11 | Month | 07 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 11 | Month | 07 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 11 | Month | 07 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 11 | Month | 07 | Day |
Last modified on
| 2023 | Year | 11 | Month | 07 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060145
