UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050800 |
|---|---|
| Receipt number | R000057889 |
| Scientific Title | Effect of lactic acid bacterial strain H61 on minor health complaints caused by mental stress |
| Date of disclosure of the study information | 2023/05/08 |
| Last modified on | 2025/04/11 10:34:58 |
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Basic information
Public title
Effect of lactic acid bacterial strain H61 on minor health complaints caused by mental stress
Acronym
Effect of lactic acid bacterial strain H61 on minor health complaints caused by mental stress
Scientific Title
Effect of lactic acid bacterial strain H61 on minor health complaints caused by mental stress
Scientific Title:Acronym
Effect of lactic acid bacterial strain H61 on minor health complaints caused by mental stress
Region
| Japan |
Condition
Condition
minor health complaints
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate effect of functional lactic acid bacteria, strain H61 on minor health complaints caused by mental stress.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
minor health complaints
Key secondary outcomes
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
8 weeks, 1 tablet containing lactic acid bacterial strain H61 (heat-killed cells)
Interventions/Control_2
8 weeks, 1 tablet containing starch
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy person with minor health complaints
Key exclusion criteria
Exclusion criteria is pregnancy, breast-feeding, those who routinely used medical products and GABA supplement, those who have food allergy, those who have trouble on constipation, those who change life style drastically.
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | Hiromi |
| Middle name | |
| Last name | Kimoto |
Organization
National Agricultural and Food Organization
Division name
Institute of Food Research
Zip code
305-8642
Address
Kannondai 2-1-12, Tsukuba
TEL
029-838-7981
anne@affrc.go.jp
Public contact
Name of contact person
| 1st name | Hiromi |
| Middle name | |
| Last name | Kimoto |
Organization
National Agricultural and Food Organization
Division name
Institute of Food Research
Zip code
305-8642
Address
Kannondai 2-1-12, Tsukuba
TEL
029-838-7981
Homepage URL
anne@affrc.go.jp
Sponsor or person
Institute
National Agricultural and Food Organization
Institute
Department
Personal name
Funding Source
Organization
National Agricultural and Food Organization
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Agricultural and Food Organization
Address
Kannondai 2-1-12, Tsukuba
Tel
029-838-7981
anne@affrc.go.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
| 2023 | Year | 05 | Month | 08 | Day |
Related information
URL releasing protocol
None
Publication of results
Partially published
Result
URL related to results and publications
None
Number of participants that the trial has enrolled
33
Results
A certain sleep score expressed visual analogue scale and attentiveness at 4 week tented to be improved in test group compared with placebo group.
Results date posted
| 2025 | Year | 04 | Month | 11 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy people
Participant flow
Drop out : 1 people Exclusion criteria: 1 people
Adverse events
None
Outcome measures
Sleep score
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2022 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2023 | Year | 05 | Month | 08 | 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 | 04 | Month | 10 | Day |
Last modified on
| 2025 | Year | 04 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057889
